Trial Outcomes & Findings for An Observational Study of The Safety of MabThera/Rituxan (Rituximab) in Participants With Granulomatosis With Polyangiitis (Wegener's) or Microscopic Polyangiitis (NCT NCT01613599)
NCT ID: NCT01613599
Last Updated: 2018-07-26
Results Overview
A serious infection was defined as an infection that was a serious adverse event (SAE) or a non-SAE infection that required treatment with intravenous antimicrobials. A SAE was defined as any adverse event that fulfilled at least one of the following criteria: •Was fatal (results in death) •Was 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 one or other of the outcomes listed above. Multiple events reported in the same participant were counted multiple times in the calculation of incidence. Incidence rate is defined as events per 100 patient years.
COMPLETED
100 participants
From first dose until participant withdrawal or the date of last participant, last visit (up to 4.32 years)
2018-07-26
Participant Flow
A total of 100 participants were enrolled in 15 investigational sites in United States. 3 participants out of 100 enrolled participants were not included in the analysis population as that site became unresponsive.
Participant milestones
| Measure |
Rituximab
Participants with granulomatosis with polyangiitis (GPA) (Wegener's granulomatosis) or microscopic polyangiitis (MPA) who received rituximab as per investigator's discretion were followed for a maximum of 4.32 years.
|
|---|---|
|
Overall Study
STARTED
|
97
|
|
Overall Study
COMPLETED
|
72
|
|
Overall Study
NOT COMPLETED
|
25
|
Reasons for withdrawal
| Measure |
Rituximab
Participants with granulomatosis with polyangiitis (GPA) (Wegener's granulomatosis) or microscopic polyangiitis (MPA) who received rituximab as per investigator's discretion were followed for a maximum of 4.32 years.
|
|---|---|
|
Overall Study
Death
|
9
|
|
Overall Study
Lost to Follow-up
|
5
|
|
Overall Study
Withdrawal by Subject
|
8
|
|
Overall Study
Reason not specified
|
3
|
Baseline Characteristics
An Observational Study of The Safety of MabThera/Rituxan (Rituximab) in Participants With Granulomatosis With Polyangiitis (Wegener's) or Microscopic Polyangiitis
Baseline characteristics by cohort
| Measure |
Rituximab
n=97 Participants
Participants with GPA (Wegener's granulomatosis) or MPA who received rituximab as per investigator's discretion were followed for a maximum of 4.32 years.
|
|---|---|
|
Age, Continuous
|
56.3 years
STANDARD_DEVIATION 16.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
57 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
40 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From first dose until participant withdrawal or the date of last participant, last visit (up to 4.32 years)Population: The safety population included all participants who received any active dose of rituximab.
A serious infection was defined as an infection that was a serious adverse event (SAE) or a non-SAE infection that required treatment with intravenous antimicrobials. A SAE was defined as any adverse event that fulfilled at least one of the following criteria: •Was fatal (results in death) •Was 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 one or other of the outcomes listed above. Multiple events reported in the same participant were counted multiple times in the calculation of incidence. Incidence rate is defined as events per 100 patient years.
Outcome measures
| Measure |
Rituximab
n=338 Total Patient-years at Risk
Participants with GPA (Wegener's granulomatosis) or MPA who received rituximab as per investigator's discretion were followed for a maximum of 4.32 years.
|
|---|---|
|
Incidence Rate of Serious Infections
|
7.11 events per 100 patient year
Interval 4.55 to 10.58
|
SECONDARY outcome
Timeframe: From the start of an infusion up to 24 hours following infusion completion (Up to 4.32 years)Population: The safety population included all participants who received any active dose of rituximab.
A serious infusion-related reaction was defined as a SAE during or within 24 hours after any rituximab infusion and considered infusion related by the Principal Investigator. A SAE was defined as any adverse event that fulfilled at least one of the following criteria: •Was fatal (results in death) •Was 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 one or other of the outcomes listed above.
Outcome measures
| Measure |
Rituximab
n=97 Participants
Participants with GPA (Wegener's granulomatosis) or MPA who received rituximab as per investigator's discretion were followed for a maximum of 4.32 years.
|
|---|---|
|
Percentage of Participants With a Serious Infusion-related Reaction
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: From first dose until participant withdrawal or the date of last participant, last visit (up to 4.32 years)Population: The safety population included all participants who received any active dose of rituximab.
A serious cardiac adverse event was defined as a SAE that was coded to the Medical Dictionary for Regulatory Activities (MedDRA) cardiac system organ class. A SAE was defined as any adverse event that fulfilled at least one of the following criteria: •Was fatal (results in death) •Was 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 one or other of the outcomes listed above. Multiple events reported in the same participant were counted multiple times in the calculation of incidence. Incidence rate is defined as events per 100 patient years.
Outcome measures
| Measure |
Rituximab
n=338 Total Patient-years at Risk
Participants with GPA (Wegener's granulomatosis) or MPA who received rituximab as per investigator's discretion were followed for a maximum of 4.32 years.
|
|---|---|
|
Incidence Rate of Serious Cardiac Adverse Events
|
5.03 events per 100 patient year
Interval 2.93 to 8.06
|
SECONDARY outcome
Timeframe: From the start of an infusion up to 24 hours following infusion completion (Up to 4.32 years)Population: The safety population included all participants who received any active dose of rituximab.
A SAE was defined as any adverse event that fulfilled at least one of the following criteria: •Was fatal (results in death) •Was 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 one or other of the outcomes listed above.
Outcome measures
| Measure |
Rituximab
n=97 Participants
Participants with GPA (Wegener's granulomatosis) or MPA who received rituximab as per investigator's discretion were followed for a maximum of 4.32 years.
|
|---|---|
|
Percentage of Participants With Any Serious Adverse Events During or Within 24 Hours After Any Rituximab Infusion
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: From first dose until participant withdrawal or the date of last participant, last visit (up to 4.32 years)Population: The safety population included all participants who received any active dose of rituximab.
A serious vascular adverse event was defined as a SAE coded to the MedDRA vascular system organ class. A SAE was defined as any adverse event that fulfilled at least one of the following criteria: •Was fatal (results in death) •Was 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 one or other of the outcomes listed above. Multiple events reported in the same participant were counted multiple times in the calculation of incidence. Incidence rate is defined as events per 100 patient years.
Outcome measures
| Measure |
Rituximab
n=338 Total Patient-years at Risk
Participants with GPA (Wegener's granulomatosis) or MPA who received rituximab as per investigator's discretion were followed for a maximum of 4.32 years.
|
|---|---|
|
Incidence Rate of Serious Vascular Adverse Events
|
2.37 events per 100 patient year
Interval 1.02 to 4.67
|
SECONDARY outcome
Timeframe: From first dose until participant withdrawal or the date of last participant, last visit (up to 4.32 years)Population: The safety population included all participants who received any active dose of rituximab.
Malignancies were clinical findings of cancer and excluded non-melanoma skin cancer. Multiple events reported in the same participant were counted multiple times in the calculation of incidence. Incidence rate is defined as events per 100 patient years.
Outcome measures
| Measure |
Rituximab
n=338 Total Patient-years at Risk
Participants with GPA (Wegener's granulomatosis) or MPA who received rituximab as per investigator's discretion were followed for a maximum of 4.32 years.
|
|---|---|
|
Incidence Rate of Malignancy, Excluding Non-melanoma Skin Cancer
|
0.89 events per 100 patient year
Interval 0.18 to 2.6
|
SECONDARY outcome
Timeframe: From first dose until participant withdrawal or the date of last participant, last visit (up to 4.32 years)Population: The safety population included all participants who received any active dose of rituximab.
A SAE was defined as any adverse event that fulfilled at least one of the following criteria: •Was fatal (results in death) •Was 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 one or other of the outcomes listed above. Multiple events reported in the same participant were counted multiple times in the calculation of incidence. Incidence rate is defined as events per 100 patient years.
Outcome measures
| Measure |
Rituximab
n=338 Total Patient-years at Risk
Participants with GPA (Wegener's granulomatosis) or MPA who received rituximab as per investigator's discretion were followed for a maximum of 4.32 years.
|
|---|---|
|
Incidence Rate of Serious Adverse Events
|
27.84 events per 100 patient year
Interval 22.5 to 34.07
|
SECONDARY outcome
Timeframe: From first dose until participant withdrawal or the date of last participant, last visit (up to 4.32 years)Population: The safety population included all participants who received any active dose of rituximab.
Incidence rate is defined as events per 100 patient years.
Outcome measures
| Measure |
Rituximab
n=338 Total Patient-years at Risk
Participants with GPA (Wegener's granulomatosis) or MPA who received rituximab as per investigator's discretion were followed for a maximum of 4.32 years.
|
|---|---|
|
Incidence Rate of Adverse Events With Fatal Outcomes
|
2.67 events per 100 patient year
Interval 1.22 to 5.06
|
SECONDARY outcome
Timeframe: From first dose until participant withdrawal or the date of last participant, last visit (up to 4.32 years)Population: The re-treated safety population was a subset of the safety population and included all participants who received more than one course of rituximab.
A SAE was defined as any adverse event that fulfilled at least one of the following criteria: •Was fatal (results in death) •Was 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 one or other of the outcomes listed above. Multiple events reported in the same participant were counted multiple times in the calculation of incidence. Incidence rate is defined as events per 100 patient years.
Outcome measures
| Measure |
Rituximab
n=264 Total Patient-years at Risk
Participants with GPA (Wegener's granulomatosis) or MPA who received rituximab as per investigator's discretion were followed for a maximum of 4.32 years.
|
|---|---|
|
Incidence Rate of Serious Adverse Events in Participants Who Received Re-treatment With MabThera/Rituximab
|
23.90 events per 100 patient year
Interval 18.36 to 30.58
|
SECONDARY outcome
Timeframe: From first dose until participant withdrawal or the date of last participant, last visit (up to 4.32 years)Population: The re-treated safety population was a subset of the safety population and included all participants who received more than one course of rituximab.
A serious infection was defined as an infection that was a serious adverse event (SAE) or a non-SAE infection that required treatment with intravenous antimicrobials. A SAE was defined as any adverse event that fulfilled at least one of the following criteria: •Was fatal (results in death) •Was 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 one or other of the outcomes listed above. Multiple events reported in the same participant were counted multiple times in the calculation of incidence. Incidence rate is defined as events per 100 patient years.
Outcome measures
| Measure |
Rituximab
n=264 Total Patient-years at Risk
Participants with GPA (Wegener's granulomatosis) or MPA who received rituximab as per investigator's discretion were followed for a maximum of 4.32 years.
|
|---|---|
|
Incidence Rate of Serious Infections in Participants Who Received Re-treatment With MabThera/Rituximab
|
6.07 events per 100 patient year
Interval 3.47 to 9.86
|
Adverse Events
Rituximab
Serious adverse events
| Measure |
Rituximab
n=97 participants at risk
Participants with GPA (Wegener's granulomatosis) or MPA who received rituximab as per investigator's discretion were followed for a maximum of 4.32 years
|
|---|---|
|
Infections and infestations
Gastroenteritis
|
2.1%
2/97 • Enrollment of the first participant to time of withdrawal or last participant visit (Up to 4.32 years)
|
|
Infections and infestations
Influenza
|
2.1%
2/97 • Enrollment of the first participant to time of withdrawal or last participant visit (Up to 4.32 years)
|
|
Infections and infestations
Pneumonia
|
2.1%
2/97 • Enrollment of the first participant to time of withdrawal or last participant visit (Up to 4.32 years)
|
|
Infections and infestations
Staphylococcal bacteraemia
|
2.1%
2/97 • Enrollment of the first participant to time of withdrawal or last participant visit (Up to 4.32 years)
|
|
Infections and infestations
Bacteraemia
|
1.0%
1/97 • Enrollment of the first participant to time of withdrawal or last participant visit (Up to 4.32 years)
|
|
Infections and infestations
Bronchitis
|
1.0%
1/97 • Enrollment of the first participant to time of withdrawal or last participant visit (Up to 4.32 years)
|
|
Infections and infestations
Cellulitis
|
1.0%
1/97 • Enrollment of the first participant to time of withdrawal or last participant visit (Up to 4.32 years)
|
|
Infections and infestations
Endocarditis
|
1.0%
1/97 • Enrollment of the first participant to time of withdrawal or last participant visit (Up to 4.32 years)
|
|
Infections and infestations
Herpes zoster
|
2.1%
2/97 • Enrollment of the first participant to time of withdrawal or last participant visit (Up to 4.32 years)
|
|
Infections and infestations
Pneumonia bacterial
|
1.0%
1/97 • Enrollment of the first participant to time of withdrawal or last participant visit (Up to 4.32 years)
|
|
Infections and infestations
Pneumonia legionella
|
1.0%
1/97 • Enrollment of the first participant to time of withdrawal or last participant visit (Up to 4.32 years)
|
|
Infections and infestations
Sepsis
|
1.0%
1/97 • Enrollment of the first participant to time of withdrawal or last participant visit (Up to 4.32 years)
|
|
Infections and infestations
Septic shock
|
1.0%
1/97 • Enrollment of the first participant to time of withdrawal or last participant visit (Up to 4.32 years)
|
|
Infections and infestations
Urinary tract infection
|
2.1%
2/97 • Enrollment of the first participant to time of withdrawal or last participant visit (Up to 4.32 years)
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
2.1%
2/97 • Enrollment of the first participant to time of withdrawal or last participant visit (Up to 4.32 years)
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
2.1%
2/97 • Enrollment of the first participant to time of withdrawal or last participant visit (Up to 4.32 years)
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal stenosis
|
2.1%
2/97 • Enrollment of the first participant to time of withdrawal or last participant visit (Up to 4.32 years)
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
1.0%
1/97 • Enrollment of the first participant to time of withdrawal or last participant visit (Up to 4.32 years)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.0%
1/97 • Enrollment of the first participant to time of withdrawal or last participant visit (Up to 4.32 years)
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
1.0%
1/97 • Enrollment of the first participant to time of withdrawal or last participant visit (Up to 4.32 years)
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothroax
|
1.0%
1/97 • Enrollment of the first participant to time of withdrawal or last participant visit (Up to 4.32 years)
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax spontaneous
|
1.0%
1/97 • Enrollment of the first participant to time of withdrawal or last participant visit (Up to 4.32 years)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary alveolar haemorrhage
|
1.0%
1/97 • Enrollment of the first participant to time of withdrawal or last participant visit (Up to 4.32 years)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.0%
1/97 • Enrollment of the first participant to time of withdrawal or last participant visit (Up to 4.32 years)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
1.0%
1/97 • Enrollment of the first participant to time of withdrawal or last participant visit (Up to 4.32 years)
|
|
Cardiac disorders
Atrial fibrillation
|
5.2%
5/97 • Enrollment of the first participant to time of withdrawal or last participant visit (Up to 4.32 years)
|
|
Cardiac disorders
Atrial flutter
|
2.1%
2/97 • Enrollment of the first participant to time of withdrawal or last participant visit (Up to 4.32 years)
|
|
Cardiac disorders
Angina pectoris
|
1.0%
1/97 • Enrollment of the first participant to time of withdrawal or last participant visit (Up to 4.32 years)
|
|
Cardiac disorders
Cardiac failure congestive
|
1.0%
1/97 • Enrollment of the first participant to time of withdrawal or last participant visit (Up to 4.32 years)
|
|
Cardiac disorders
Cardio-respiratory arrest
|
1.0%
1/97 • Enrollment of the first participant to time of withdrawal or last participant visit (Up to 4.32 years)
|
|
Cardiac disorders
Myocardial infarction
|
1.0%
1/97 • Enrollment of the first participant to time of withdrawal or last participant visit (Up to 4.32 years)
|
|
Cardiac disorders
Supraventricular tachycardia
|
1.0%
1/97 • Enrollment of the first participant to time of withdrawal or last participant visit (Up to 4.32 years)
|
|
Vascular disorders
Deep vein thrombosis
|
5.2%
5/97 • Enrollment of the first participant to time of withdrawal or last participant visit (Up to 4.32 years)
|
|
Vascular disorders
Orthostatic hypotension
|
1.0%
1/97 • Enrollment of the first participant to time of withdrawal or last participant visit (Up to 4.32 years)
|
|
Gastrointestinal disorders
Abdominal pain
|
1.0%
1/97 • Enrollment of the first participant to time of withdrawal or last participant visit (Up to 4.32 years)
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
1.0%
1/97 • Enrollment of the first participant to time of withdrawal or last participant visit (Up to 4.32 years)
|
|
Gastrointestinal disorders
Oesophagitis
|
1.0%
1/97 • Enrollment of the first participant to time of withdrawal or last participant visit (Up to 4.32 years)
|
|
General disorders
Death
|
4.1%
4/97 • Enrollment of the first participant to time of withdrawal or last participant visit (Up to 4.32 years)
|
|
General disorders
Chest pain
|
2.1%
2/97 • Enrollment of the first participant to time of withdrawal or last participant visit (Up to 4.32 years)
|
|
Metabolism and nutrition disorders
Fluid overload
|
1.0%
1/97 • Enrollment of the first participant to time of withdrawal or last participant visit (Up to 4.32 years)
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
1.0%
1/97 • Enrollment of the first participant to time of withdrawal or last participant visit (Up to 4.32 years)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.0%
1/97 • Enrollment of the first participant to time of withdrawal or last participant visit (Up to 4.32 years)
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
1.0%
1/97 • Enrollment of the first participant to time of withdrawal or last participant visit (Up to 4.32 years)
|
|
Nervous system disorders
Ischaemic stroke
|
1.0%
1/97 • Enrollment of the first participant to time of withdrawal or last participant visit (Up to 4.32 years)
|
|
Nervous system disorders
Metabolic encephalopathy
|
1.0%
1/97 • Enrollment of the first participant to time of withdrawal or last participant visit (Up to 4.32 years)
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
1.0%
1/97 • Enrollment of the first participant to time of withdrawal or last participant visit (Up to 4.32 years)
|
|
Ear and labyrinth disorders
Vertigo
|
1.0%
1/97 • Enrollment of the first participant to time of withdrawal or last participant visit (Up to 4.32 years)
|
|
Injury, poisoning and procedural complications
Pubis fracture
|
1.0%
1/97 • Enrollment of the first participant to time of withdrawal or last participant visit (Up to 4.32 years)
|
|
Investigations
Blood creatinine increased
|
1.0%
1/97 • Enrollment of the first participant to time of withdrawal or last participant visit (Up to 4.32 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma
|
1.0%
1/97 • Enrollment of the first participant to time of withdrawal or last participant visit (Up to 4.32 years)
|
|
Renal and urinary disorders
Cystitis haemorrhagic
|
1.0%
1/97 • Enrollment of the first participant to time of withdrawal or last participant visit (Up to 4.32 years)
|
|
Surgical and medical procedures
Renal transplant
|
1.0%
1/97 • Enrollment of the first participant to time of withdrawal or last participant visit (Up to 4.32 years)
|
|
Cardiac disorders
Atrial tachycardia
|
1.0%
1/97 • Enrollment of the first participant to time of withdrawal or last participant visit (Up to 4.32 years)
|
|
Cardiac disorders
Bradycardia
|
1.0%
1/97 • Enrollment of the first participant to time of withdrawal or last participant visit (Up to 4.32 years)
|
|
Ear and labyrinth disorders
Vertigo positional
|
1.0%
1/97 • Enrollment of the first participant to time of withdrawal or last participant visit (Up to 4.32 years)
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
1.0%
1/97 • Enrollment of the first participant to time of withdrawal or last participant visit (Up to 4.32 years)
|
|
General disorders
Asthenia
|
1.0%
1/97 • Enrollment of the first participant to time of withdrawal or last participant visit (Up to 4.32 years)
|
|
Infections and infestations
Upper respiratory tract infection
|
1.0%
1/97 • Enrollment of the first participant to time of withdrawal or last participant visit (Up to 4.32 years)
|
|
Injury, poisoning and procedural complications
Fall
|
1.0%
1/97 • Enrollment of the first participant to time of withdrawal or last participant visit (Up to 4.32 years)
|
|
Injury, poisoning and procedural complications
Hip fracture
|
1.0%
1/97 • Enrollment of the first participant to time of withdrawal or last participant visit (Up to 4.32 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
1.0%
1/97 • Enrollment of the first participant to time of withdrawal or last participant visit (Up to 4.32 years)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
1.0%
1/97 • Enrollment of the first participant to time of withdrawal or last participant visit (Up to 4.32 years)
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
1.0%
1/97 • Enrollment of the first participant to time of withdrawal or last participant visit (Up to 4.32 years)
|
|
Vascular disorders
Haematoma
|
1.0%
1/97 • Enrollment of the first participant to time of withdrawal or last participant visit (Up to 4.32 years)
|
Other adverse events
| Measure |
Rituximab
n=97 participants at risk
Participants with GPA (Wegener's granulomatosis) or MPA who received rituximab as per investigator's discretion were followed for a maximum of 4.32 years
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
5.2%
5/97 • Enrollment of the first participant to time of withdrawal or last participant visit (Up to 4.32 years)
|
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 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