Trial Outcomes & Findings for Efficacy and Safety Study to Evaluate Gadavist (Gadobutrol) as Contrast Agent in Magnetic Resonance Imaging (MRI) of Vascular Diseases in Chinese Patients (NCT NCT00395733)

Last Updated: 2013-12-18

Results Overview

Each arterial segment visualized in magnetic resonance angiography (MRA) enhanced by Gadavist and Magnevist was characterized by the on-site investigators and by three independent blinded readers (reader 1, 2 and 3) according to a five-point scale (none/not assessable, poor, moderate, good, excellent), which takes into consideration intravascular contrast quality as well as vessel border delineation. The number of vessel segments with adequate diagnostic quality, i.e. good or excellent scores, was determined for each MRA image.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

83 participants

Primary outcome timeframe

20-30 seconds after injection

Results posted on

2013-12-18

Participant Flow

Participants were recruited at specialized study centers if they satisfied the inclusion and exclusion criteria. All had known or suspected stenosis of arterial vessels in different vascular body regions with an indication for contrast-enhanced magnetic resonance angiography for diagnosis and further treatment.

Of 87 screened participants, 4 were not randomized (2 due to withdrawal of consent, 1 due to entering another clinical study and 1 was lost to follow-up). Thus, 83 participants were randomized to either the sequence Gadobutrol/Gadopentate dimeglumine (41 participants) or Gadopentate dimeglumine/Gadobutrol (42 participants).

Participant milestones

Participant milestones
Measure	Period 1: Gadobutrol, Period 2: Gadopentate Dimeglumine Period 1: Gadobutrol 0.2 - 0.3 mmol/kg Body Weight (BW) (Gadavist, BAY86-4875); Participant received a single intravenous injection with Gadobutrol (1.0 M) at a volume of 0.2 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.3 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW). Period 2: Gadopentate dimeglumine 0.2 - 0.3 mmol/kg BW (Magnevist, BAY86-4882); Participant received a single intravenous injection with Gadopentate (0.5 M) at a volume of 0.4 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.6 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW).	Period 1: Gadopentate Dimeglumine, Period 2: Gadobutrol Period 1: Gadopentate dimeglumine 0.2 - 0.3 mmol/kg BW (Magnevist, BAY86-4882); Participant received a single intravenous injection with Gadopentate (0.5 M) at a volume of 0.4 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.6 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW). Period 2: Gadobutrol 0.2 - 0.3 mmol/kg BW (Gadavist, BAY86-4875); Participant received a single intravenous injection with Gadobutrol (1.0 M) at a volume of 0.2 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.3 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW).
Period 1 STARTED	41	42
Period 1 COMPLETED	41	42
Period 1 NOT COMPLETED	0	0
Period 2 STARTED	41	42
Period 2 COMPLETED	39	37
Period 2 NOT COMPLETED	2	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Period 1: Gadobutrol, Period 2: Gadopentate Dimeglumine Period 1: Gadobutrol 0.2 - 0.3 mmol/kg Body Weight (BW) (Gadavist, BAY86-4875); Participant received a single intravenous injection with Gadobutrol (1.0 M) at a volume of 0.2 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.3 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW). Period 2: Gadopentate dimeglumine 0.2 - 0.3 mmol/kg BW (Magnevist, BAY86-4882); Participant received a single intravenous injection with Gadopentate (0.5 M) at a volume of 0.4 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.6 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW).	Period 1: Gadopentate Dimeglumine, Period 2: Gadobutrol Period 1: Gadopentate dimeglumine 0.2 - 0.3 mmol/kg BW (Magnevist, BAY86-4882); Participant received a single intravenous injection with Gadopentate (0.5 M) at a volume of 0.4 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.6 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW). Period 2: Gadobutrol 0.2 - 0.3 mmol/kg BW (Gadavist, BAY86-4875); Participant received a single intravenous injection with Gadobutrol (1.0 M) at a volume of 0.2 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.3 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW).
Period 2 Withdrawal by Subject	1	2
Period 2 Protocol Violation	0	1
Period 2 Adverse Event	0	2
Period 2 Technical problems	1	0

Baseline Characteristics

Efficacy and Safety Study to Evaluate Gadavist (Gadobutrol) as Contrast Agent in Magnetic Resonance Imaging (MRI) of Vascular Diseases in Chinese Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Period 1: Gadobutrol, Period 2: Gadopentate Dimeglumine n=41 Participants Period 1: Participant received a single intravenous injection with Gadobutrol (1.0 M) at a volume of 0.2 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.3 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW). Period 2: Participant received a single intravenous injection with Gadopentate (0.5 M) at a volume of 0.4 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.6 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW).	Period 1: Gadopentate Dimeglumine, Period 2: Gadobutrol n=42 Participants Period 1: Participant received a single intravenous injection with Gadopentate (0.5 M) at a volume of 0.4 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.6 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW). Period 2: Participant received a single intravenous injection with Gadobutrol (1.0 M) at a volume of 0.2 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.3 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW).	Total n=83 Participants Total of all reporting groups
Age, Continuous	50.8 Years STANDARD_DEVIATION 14.26 • n=5 Participants	55.3 Years STANDARD_DEVIATION 11.21 • n=7 Participants	53.1 Years STANDARD_DEVIATION 12.93 • n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants	15 Participants n=7 Participants	29 Participants n=5 Participants
Sex: Female, Male Male	27 Participants n=5 Participants	27 Participants n=7 Participants	54 Participants n=5 Participants

PRIMARY outcome

Timeframe: 20-30 seconds after injection

Population: Per Protocol Set (PPS): All participants who have received contrast injection and are not invalid cases. Note: The contrast enhanced MR image from one participant was lost after assessment by the investigator, i.e. the PPS analysis for the blinded readers is based on the images of 66 participants only.

Outcome measures

Outcome measures
Measure	Gadobutrol (Gadavist, BAY86-4875) n=67 Participants Participant received a single intravenous injection with Gadobutrol (1.0 M) at a volume of 0.2 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.3 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW)	Gadopentate Dimeglumine (Magnevist, BAY86-4882) n=67 Participants Participant received a single intravenous injection with Gadopentate (0.5 M) at a volume of 0.4 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.6 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW)
Number of Vessel Segments Visualized With Diagnostic Quality Investigators	8.10 vessel segments Standard Deviation 3.685	8.33 vessel segments Standard Deviation 3.755
Number of Vessel Segments Visualized With Diagnostic Quality Reader 1	8.03 vessel segments Standard Deviation 3.815	8.33 vessel segments Standard Deviation 3.852
Number of Vessel Segments Visualized With Diagnostic Quality Reader 2	7.55 vessel segments Standard Deviation 4.622	7.88 vessel segments Standard Deviation 3.665
Number of Vessel Segments Visualized With Diagnostic Quality Reader 3	5.27 vessel segments Standard Deviation 3.921	5.91 vessel segments Standard Deviation 3.666

SECONDARY outcome

Timeframe: immediately before and 20-30 seconds after injection (precontrast and postcontrast)

Population: Per Protocol Set (PPS): All participants who have received contrast injection and are not invalid cases.

The on-site investigators assessed the change in diagnostic confidence in the assessment of MRA scans before and after injection with Gadavist and Magnevist for each participant on a three-point scale as improved, unchanged or worsened.

Outcome measures

Outcome measures
Measure	Gadobutrol (Gadavist, BAY86-4875) n=67 Participants Participant received a single intravenous injection with Gadobutrol (1.0 M) at a volume of 0.2 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.3 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW)	Gadopentate Dimeglumine (Magnevist, BAY86-4882) n=67 Participants Participant received a single intravenous injection with Gadopentate (0.5 M) at a volume of 0.4 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.6 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW)
Change in Diagnostic Confidence From Pre- to Post-contrast MRA by Investigator improved	63 Participants	65 Participants
Change in Diagnostic Confidence From Pre- to Post-contrast MRA by Investigator unchanged	0 Participants	0 Participants
Change in Diagnostic Confidence From Pre- to Post-contrast MRA by Investigator worsened	0 Participants	0 Participants
Change in Diagnostic Confidence From Pre- to Post-contrast MRA by Investigator missing or not applicable	4 Participants	2 Participants

SECONDARY outcome

Timeframe: immediately before and 20-30 seconds after injection (precontrast and postcontrast)

Independent blinded reader 1 assessed the change in diagnostic confidence in the assessment of MRA scans before and after injection with Gadavist and Magnevist for each participant on a three-point scale as improved, unchanged or worsened.

Outcome measures

Outcome measures
Measure	Gadobutrol (Gadavist, BAY86-4875) n=66 Participants Participant received a single intravenous injection with Gadobutrol (1.0 M) at a volume of 0.2 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.3 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW)	Gadopentate Dimeglumine (Magnevist, BAY86-4882) n=66 Participants Participant received a single intravenous injection with Gadopentate (0.5 M) at a volume of 0.4 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.6 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW)
Change in Diagnostic Confidence From Pre- to Post-contrast MRA by Blinded Reader 1 improved	61 Participants	63 Participants
Change in Diagnostic Confidence From Pre- to Post-contrast MRA by Blinded Reader 1 unchanged	0 Participants	0 Participants
Change in Diagnostic Confidence From Pre- to Post-contrast MRA by Blinded Reader 1 worsened	1 Participants	0 Participants
Change in Diagnostic Confidence From Pre- to Post-contrast MRA by Blinded Reader 1 missing or not applicable	4 Participants	3 Participants

SECONDARY outcome

Timeframe: immediately before and 20-30 seconds after injection (precontrast and postcontrast)

Independent blinded reader 2 assessed the change in diagnostic confidence in the assessment of MRA scans before and after injection with Gadavist and Magnevist for each participant on a three-point scale as improved, unchanged or worsened.

Outcome measures

Outcome measures
Measure	Gadobutrol (Gadavist, BAY86-4875) n=66 Participants Participant received a single intravenous injection with Gadobutrol (1.0 M) at a volume of 0.2 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.3 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW)	Gadopentate Dimeglumine (Magnevist, BAY86-4882) n=66 Participants Participant received a single intravenous injection with Gadopentate (0.5 M) at a volume of 0.4 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.6 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW)
Change in Diagnostic Confidence From Pre- to Post-contrast MRA by Blinded Reader 2 improved	56 Participants	63 Participants
Change in Diagnostic Confidence From Pre- to Post-contrast MRA by Blinded Reader 2 unchanged	3 Participants	1 Participants
Change in Diagnostic Confidence From Pre- to Post-contrast MRA by Blinded Reader 2 worsened	1 Participants	0 Participants
Change in Diagnostic Confidence From Pre- to Post-contrast MRA by Blinded Reader 2 missing or not applicable	6 Participants	2 Participants

SECONDARY outcome

Timeframe: immediately before and 20-30 seconds after injection (precontrast and postcontrast)

Independent blinded reader 3 assessed the change in diagnostic confidence in the assessment of MRA scans before and after injection with Gadavist and Magnevist for each participant on a three-point scale as improved, unchanged or worsened.

Outcome measures

Outcome measures
Measure	Gadobutrol (Gadavist, BAY86-4875) n=66 Participants Participant received a single intravenous injection with Gadobutrol (1.0 M) at a volume of 0.2 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.3 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW)	Gadopentate Dimeglumine (Magnevist, BAY86-4882) n=66 Participants Participant received a single intravenous injection with Gadopentate (0.5 M) at a volume of 0.4 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.6 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW)
Change in Diagnostic Confidence From Pre- to Post-contrast MRA by Blinded Reader 3 improved	59 Participants	63 Participants
Change in Diagnostic Confidence From Pre- to Post-contrast MRA by Blinded Reader 3 unchanged	0 Participants	0 Participants
Change in Diagnostic Confidence From Pre- to Post-contrast MRA by Blinded Reader 3 worsened	2 Participants	0 Participants
Change in Diagnostic Confidence From Pre- to Post-contrast MRA by Blinded Reader 3 missing or not applicable	5 Participants	3 Participants

SECONDARY outcome

Timeframe: 20-30 seconds after injection

Population: Per Protocol Set (PPS): All participants who have received contrast injection and are not invalid cases.

The MRA diagnosis describes the pathology with regard to the extent of a stenosis, i.e., normal (no relevant disease), advanced arteriosclerosis but stenosis \<= 50% (exemption: internal carotid artery: stenosis \<= 70%), advanced arteriosclerosis, stenosis \>50% but \<99% (stenosis 50-99%) (exemption: internal carotid artery \>70%), occlusion, and not assessable.

Outcome measures

Outcome measures
Measure	Gadobutrol (Gadavist, BAY86-4875) n=67 Participants Participant received a single intravenous injection with Gadobutrol (1.0 M) at a volume of 0.2 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.3 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW)	Gadopentate Dimeglumine (Magnevist, BAY86-4882) n=67 Participants Participant received a single intravenous injection with Gadopentate (0.5 M) at a volume of 0.4 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.6 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW)
MRA Diagnosis by Investigators 100% diameter reduction (occlusion)	6 Vessels	8 Vessels
MRA Diagnosis by Investigators normal	494 Vessels	504 Vessels
MRA Diagnosis by Investigators <= 50% stenosis	47 Vessels	30 Vessels
MRA Diagnosis by Investigators > 50% stenosis	32 Vessels	32 Vessels
MRA Diagnosis by Investigators stenosis <= 70%	5 Vessels	3 Vessels
MRA Diagnosis by Investigators stenosis > 70%	0 Vessels	0 Vessels
MRA Diagnosis by Investigators not assessable	271 Vessels	278 Vessels

SECONDARY outcome

Timeframe: 20-30 seconds after injection

Outcome measures

Outcome measures
Measure	Gadobutrol (Gadavist, BAY86-4875) n=66 Participants Participant received a single intravenous injection with Gadobutrol (1.0 M) at a volume of 0.2 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.3 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW)	Gadopentate Dimeglumine (Magnevist, BAY86-4882) n=66 Participants Participant received a single intravenous injection with Gadopentate (0.5 M) at a volume of 0.4 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.6 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW)
MRA Diagnosis by Blinded Reader 1 100% diameter reduction (occlusion)	5 Vessels	5 Vessels
MRA Diagnosis by Blinded Reader 1 normal	503 Vessels	497 Vessels
MRA Diagnosis by Blinded Reader 1 stenosis <= 50%	33 Vessels	37 Vessels
MRA Diagnosis by Blinded Reader 1 stenosis > 50%	22 Vessels	24 Vessels
MRA Diagnosis by Blinded Reader 1 stenosis <= 70%	2 Vessels	1 Vessels
MRA Diagnosis by Blinded Reader 1 stenosis > 70%	1 Vessels	1 Vessels
MRA Diagnosis by Blinded Reader 1 not assessable	272 Vessels	273 Vessels

SECONDARY outcome

Timeframe: 20-30 seconds after injection

Outcome measures

Outcome measures
Measure	Gadobutrol (Gadavist, BAY86-4875) n=66 Participants Participant received a single intravenous injection with Gadobutrol (1.0 M) at a volume of 0.2 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.3 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW)	Gadopentate Dimeglumine (Magnevist, BAY86-4882) n=66 Participants Participant received a single intravenous injection with Gadopentate (0.5 M) at a volume of 0.4 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.6 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW)
MRA Diagnosis by Blinded Reader 2 100% diameter reduction (occlusion)	15 Vessels	10 Vessels
MRA Diagnosis by Blinded Reader 2 normal	503 Vessels	549 Vessels
MRA Diagnosis by Blinded Reader 2 <= 50% stenosis	83 Vessels	38 Vessels
MRA Diagnosis by Blinded Reader 2 > 50% stenosis	21 Vessels	16 Vessels
MRA Diagnosis by Blinded Reader 2 stenosis <= 70%	1 Vessels	1 Vessels
MRA Diagnosis by Blinded Reader 2 stenosis > 70%	0 Vessels	0 Vessels
MRA Diagnosis by Blinded Reader 2 not assessable	215 Vessels	224 Vessels

SECONDARY outcome

Timeframe: 20-30 seconds after injection

Outcome measures

Outcome measures
Measure	Gadobutrol (Gadavist, BAY86-4875) n=66 Participants Participant received a single intravenous injection with Gadobutrol (1.0 M) at a volume of 0.2 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.3 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW)	Gadopentate Dimeglumine (Magnevist, BAY86-4882) n=66 Participants Participant received a single intravenous injection with Gadopentate (0.5 M) at a volume of 0.4 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.6 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW)
MRA Diagnosis by Blinded Reader 3 100% diameter reduction (occlusion)	3 Vessels	2 Vessels
MRA Diagnosis by Blinded Reader 3 normal	489 Vessels	499 Vessels
MRA Diagnosis by Blinded Reader 3 <= 50% stenosis	8 Vessels	11 Vessels
MRA Diagnosis by Blinded Reader 3 > 50% stenosis	15 Vessels	17 Vessels
MRA Diagnosis by Blinded Reader 3 stenosis <= 70%	2 Vessels	1 Vessels
MRA Diagnosis by Blinded Reader 3 stenosis > 70%	0 Vessels	0 Vessels
MRA Diagnosis by Blinded Reader 3 not assessable	321 Vessels	308 Vessels

Adverse Events

Gadobutrol (Gadavist, BAY86-4875)

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Gadopentate Dimeglumine (Magnevist, BAY86-4882)

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Gadobutrol (Gadavist, BAY86-4875) n=78 participants at risk Participant received a single intravenous injection with Gadobutrol (1.0 M) at a volume of 0.2 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.3 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW)	Gadopentate Dimeglumine (Magnevist, BAY86-4882) n=81 participants at risk Participant received a single intravenous injection with Gadopentate (0.5 M) at a volume of 0.4 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.6 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW)
Gastrointestinal disorders Nausea	1.3% 1/78 • Number of events 1	0.00% 0/81
Ear and labyrinth disorders Vertigo	1.3% 1/78 • Number of events 1	0.00% 0/81
Skin and subcutaneous tissue disorders Rash papular	0.00% 0/78	1.2% 1/81 • Number of events 1
Investigations Blood pressure increased	1.3% 1/78 • Number of events 1	0.00% 0/81
Musculoskeletal and connective tissue disorders Pain in extremity	1.3% 1/78 • Number of events 1	0.00% 0/81
Cardiac disorders Palpitations	1.3% 1/78 • Number of events 1	1.2% 1/81 • Number of events 1
Investigations C-reactive protein increased	1.3% 1/78 • Number of events 1	1.2% 1/81 • Number of events 1
Infections and infestations Bronchitis	0.00% 0/78	1.2% 1/81 • Number of events 1
General disorders Feeling hot	0.00% 0/78	1.2% 1/81 • Number of events 1
Skin and subcutaneous tissue disorders Rash	1.3% 1/78 • Number of events 1	0.00% 0/81
General disorders Oedema peripheral	0.00% 0/78	1.2% 1/81 • Number of events 1
Gastrointestinal disorders Vomiting	0.00% 0/78	1.2% 1/81 • Number of events 1
General disorders Injection site swelling	0.00% 0/78	1.2% 1/81 • Number of events 1
Investigations Protein urine present	0.00% 0/78	1.2% 1/81 • Number of events 1
Cardiac disorders Atrial fibrillation	0.00% 0/78	1.2% 1/81 • Number of events 1

Additional Information

Therapeutic Area Head

BAYER

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee PIs shall provide sponsor with an advance copy of any proposed publication or oral presentation at least ninety (90) days prior to the date of the planned submission or presentation. Sponsor shall have sixty (60) days to recommend any changes it reasonably believes are necessary for scientific purposes or to preserve the confidentiality of sponsor's confidential information. PIs agree that the adoption of such recommended changes shall not be unreasonably refused.
Publication restrictions are in place

Restriction type: OTHER