Trial Outcomes & Findings for Behavioral Pharmacology of Cannabis and Nicotine (NCT NCT04124432)
NCT ID: NCT04124432
Last Updated: 2024-04-17
Results Overview
Amount of nicotine used (determined by total volume (mL) of cigarette smoke or JUUL vapor inhaled) after cannabis exposure in each session.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
26 participants
Primary outcome timeframe
0-5 hours
Results posted on
2024-04-17
Participant Flow
Participant milestones
| Measure |
Cannabis With and Without Nicotine
This was a within-subjects, cross-over design in which all participants were exposed to all 7 conditions in a randomized order.
|
|---|---|
|
Overall Study
STARTED
|
26
|
|
Overall Study
THC + No Nicotine/Tobacco
|
23
|
|
Overall Study
THC + Ad-libitum Use of Preferred Brand Cigarettes
|
20
|
|
Overall Study
THC + Ad-libitum Use of Low Nicotine Content E-Cig (3% Nicotine JUUL)
|
24
|
|
Overall Study
THC + Ad-libitum Use of High Nicotine Content E-Cig (5% Nicotine JUUL)
|
22
|
|
Overall Study
Placebo Cannabis + Ad-libitum Use of Preferred Brand Cigarettes
|
21
|
|
Overall Study
Placebo Cannabis + Ad-libitum Use of Low Nicotine Content E-Cig (3% Nicotine JUUL)
|
22
|
|
Overall Study
Placebo Cannabis + Ad-libitum Use of High Nicotine Content E-Cig (5% Nicotine JUUL)
|
21
|
|
Overall Study
COMPLETED
|
20
|
|
Overall Study
NOT COMPLETED
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Behavioral Pharmacology of Cannabis and Nicotine
Baseline characteristics by cohort
| Measure |
Cannabis With and Without Nicotine
n=20 Participants
This was a within-subjects, cross-over design in which all participants were exposed to all 7 conditions in a randomized order.
|
|---|---|
|
Age, Continuous
|
33.47 Years
STANDARD_DEVIATION 8.53 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 0-5 hoursPopulation: Represents study completers
Amount of nicotine used (determined by total volume (mL) of cigarette smoke or JUUL vapor inhaled) after cannabis exposure in each session.
Outcome measures
| Measure |
Active Cannabis Without Nicotine
n=20 Participants
Smoked cannabis containing active THC + No nicotine/tobacco
Cannabis: Cannabis will be smoked
|
Active Cannabis With Own Brand Cigarettes
n=20 Participants
Smoked cannabis containing active THC + ad-libitum use of preferred brand cigarettes
Cannabis: Cannabis will be smoked
Nicotine: Nicotine will be smoked or vaporized
|
Active Cannabis With Low Nicotine E-cigarette
n=20 Participants
Smoked cannabis containing active THC + ad-libitum use of low nicotine content E-Cig (3% nicotine JUUL)
Cannabis: Cannabis will be smoked
Nicotine: Nicotine will be smoked or vaporized
|
Active Cannabis With High Nicotine E-cigarette
n=20 Participants
Smoked cannabis containing active THC + ad-libitum use of high nicotine content E-Cig (5% nicotine JUUL)
Cannabis: Cannabis will be smoked
Nicotine: Nicotine will be smoked or vaporized
|
Placebo Cannabis With Own Brand Cigarettes
n=20 Participants
Smoked placebo cannabis + ad-libitum use of preferred brand cigarettes
Cannabis: Cannabis will be smoked
Nicotine: Nicotine will be smoked or vaporized
|
Placebo Cannabis With Low Nicotine E-cigarette
n=20 Participants
Smoked placebo cannabis + ad-libitum use of low nicotine content E-Cig (3% nicotine JUUL)
Cannabis: Cannabis will be smoked
Nicotine: Nicotine will be smoked or vaporized
|
Placebo Cannabis With High Nicotine E-cigarette
n=20 Participants
Smoked placebo cannabis + ad-libitum use of high nicotine content E-Cig (5% nicotine JUUL)
Cannabis: Cannabis will be smoked
Nicotine: Nicotine will be smoked or vaporized
|
|---|---|---|---|---|---|---|---|
|
Amount of Nicotine (mL of Smoke/Vapor) Inhaled
|
0 Volume in mL
Standard Deviation 0
|
489.0 Volume in mL
Standard Deviation 142.2
|
1814.0 Volume in mL
Standard Deviation 1064.0
|
1401.0 Volume in mL
Standard Deviation 1076.0
|
513.6 Volume in mL
Standard Deviation 247.2
|
1929.0 Volume in mL
Standard Deviation 2105.0
|
1390.0 Volume in mL
Standard Deviation 961.2
|
SECONDARY outcome
Timeframe: 0-5 hoursPopulation: Represents study completers
Mean Peak Change From Baseline rating (0-100) of Drug Effect on the DEQ, with 0 being no effect and 100 being maximum effect.
Outcome measures
| Measure |
Active Cannabis Without Nicotine
n=20 Participants
Smoked cannabis containing active THC + No nicotine/tobacco
Cannabis: Cannabis will be smoked
|
Active Cannabis With Own Brand Cigarettes
n=20 Participants
Smoked cannabis containing active THC + ad-libitum use of preferred brand cigarettes
Cannabis: Cannabis will be smoked
Nicotine: Nicotine will be smoked or vaporized
|
Active Cannabis With Low Nicotine E-cigarette
n=20 Participants
Smoked cannabis containing active THC + ad-libitum use of low nicotine content E-Cig (3% nicotine JUUL)
Cannabis: Cannabis will be smoked
Nicotine: Nicotine will be smoked or vaporized
|
Active Cannabis With High Nicotine E-cigarette
n=20 Participants
Smoked cannabis containing active THC + ad-libitum use of high nicotine content E-Cig (5% nicotine JUUL)
Cannabis: Cannabis will be smoked
Nicotine: Nicotine will be smoked or vaporized
|
Placebo Cannabis With Own Brand Cigarettes
n=20 Participants
Smoked placebo cannabis + ad-libitum use of preferred brand cigarettes
Cannabis: Cannabis will be smoked
Nicotine: Nicotine will be smoked or vaporized
|
Placebo Cannabis With Low Nicotine E-cigarette
n=20 Participants
Smoked placebo cannabis + ad-libitum use of low nicotine content E-Cig (3% nicotine JUUL)
Cannabis: Cannabis will be smoked
Nicotine: Nicotine will be smoked or vaporized
|
Placebo Cannabis With High Nicotine E-cigarette
n=20 Participants
Smoked placebo cannabis + ad-libitum use of high nicotine content E-Cig (5% nicotine JUUL)
Cannabis: Cannabis will be smoked
Nicotine: Nicotine will be smoked or vaporized
|
|---|---|---|---|---|---|---|---|
|
Mean Peak Change From Baseline Self-reported Drug Effect as Assessed by the Drug Effect Questionnaire (DEQ)
|
46.9 score on a scale
Standard Deviation 29.9
|
44.6 score on a scale
Standard Deviation 30.1
|
47.5 score on a scale
Standard Deviation 38.5
|
40.5 score on a scale
Standard Deviation 36.5
|
21.4 score on a scale
Standard Deviation 29.1
|
17.3 score on a scale
Standard Deviation 26.1
|
9.4 score on a scale
Standard Deviation 28.7
|
SECONDARY outcome
Timeframe: 0-5 hoursPopulation: Represents study completers
Computerized version of Digit Symbol Substitution Task will be administered to assess psychomotor performance. Total correct trials in 90-seconds. Minimum score of 0 but no maximum score (higher scores indicate better performance).
Outcome measures
| Measure |
Active Cannabis Without Nicotine
n=20 Participants
Smoked cannabis containing active THC + No nicotine/tobacco
Cannabis: Cannabis will be smoked
|
Active Cannabis With Own Brand Cigarettes
n=20 Participants
Smoked cannabis containing active THC + ad-libitum use of preferred brand cigarettes
Cannabis: Cannabis will be smoked
Nicotine: Nicotine will be smoked or vaporized
|
Active Cannabis With Low Nicotine E-cigarette
n=20 Participants
Smoked cannabis containing active THC + ad-libitum use of low nicotine content E-Cig (3% nicotine JUUL)
Cannabis: Cannabis will be smoked
Nicotine: Nicotine will be smoked or vaporized
|
Active Cannabis With High Nicotine E-cigarette
n=20 Participants
Smoked cannabis containing active THC + ad-libitum use of high nicotine content E-Cig (5% nicotine JUUL)
Cannabis: Cannabis will be smoked
Nicotine: Nicotine will be smoked or vaporized
|
Placebo Cannabis With Own Brand Cigarettes
n=20 Participants
Smoked placebo cannabis + ad-libitum use of preferred brand cigarettes
Cannabis: Cannabis will be smoked
Nicotine: Nicotine will be smoked or vaporized
|
Placebo Cannabis With Low Nicotine E-cigarette
n=20 Participants
Smoked placebo cannabis + ad-libitum use of low nicotine content E-Cig (3% nicotine JUUL)
Cannabis: Cannabis will be smoked
Nicotine: Nicotine will be smoked or vaporized
|
Placebo Cannabis With High Nicotine E-cigarette
n=20 Participants
Smoked placebo cannabis + ad-libitum use of high nicotine content E-Cig (5% nicotine JUUL)
Cannabis: Cannabis will be smoked
Nicotine: Nicotine will be smoked or vaporized
|
|---|---|---|---|---|---|---|---|
|
Mean Peak Change From Baseline Psychomotor Performance as Assessed by the Digit Symbol Substitution Task (DSST)
|
-0.2 Total correct trials
Standard Deviation 7.0
|
-0.5 Total correct trials
Standard Deviation 8.1
|
-4.3 Total correct trials
Standard Deviation 6.9
|
-3.3 Total correct trials
Standard Deviation 6.7
|
2.0 Total correct trials
Standard Deviation 5.9
|
-3.6 Total correct trials
Standard Deviation 4.3
|
-0.9 Total correct trials
Standard Deviation 8.1
|
SECONDARY outcome
Timeframe: 0-5 hoursPopulation: Represents study completers
Computerized version of Paced Auditory Serial Addition Task will be administered to assess working memory performance. Total correct trials out of 90 recorded is primary outcome (higher scores indicate better performance).
Outcome measures
| Measure |
Active Cannabis Without Nicotine
n=20 Participants
Smoked cannabis containing active THC + No nicotine/tobacco
Cannabis: Cannabis will be smoked
|
Active Cannabis With Own Brand Cigarettes
n=20 Participants
Smoked cannabis containing active THC + ad-libitum use of preferred brand cigarettes
Cannabis: Cannabis will be smoked
Nicotine: Nicotine will be smoked or vaporized
|
Active Cannabis With Low Nicotine E-cigarette
n=20 Participants
Smoked cannabis containing active THC + ad-libitum use of low nicotine content E-Cig (3% nicotine JUUL)
Cannabis: Cannabis will be smoked
Nicotine: Nicotine will be smoked or vaporized
|
Active Cannabis With High Nicotine E-cigarette
n=20 Participants
Smoked cannabis containing active THC + ad-libitum use of high nicotine content E-Cig (5% nicotine JUUL)
Cannabis: Cannabis will be smoked
Nicotine: Nicotine will be smoked or vaporized
|
Placebo Cannabis With Own Brand Cigarettes
n=20 Participants
Smoked placebo cannabis + ad-libitum use of preferred brand cigarettes
Cannabis: Cannabis will be smoked
Nicotine: Nicotine will be smoked or vaporized
|
Placebo Cannabis With Low Nicotine E-cigarette
n=20 Participants
Smoked placebo cannabis + ad-libitum use of low nicotine content E-Cig (3% nicotine JUUL)
Cannabis: Cannabis will be smoked
Nicotine: Nicotine will be smoked or vaporized
|
Placebo Cannabis With High Nicotine E-cigarette
n=20 Participants
Smoked placebo cannabis + ad-libitum use of high nicotine content E-Cig (5% nicotine JUUL)
Cannabis: Cannabis will be smoked
Nicotine: Nicotine will be smoked or vaporized
|
|---|---|---|---|---|---|---|---|
|
Mean Peak Change From Baseline Working Memory Performance as Assessed by the Paced Auditory Serial Addition Task (PASAT)
|
-3.8 Total correct trials
Standard Deviation 9.1
|
0.9 Total correct trials
Standard Deviation 15.4
|
-9.8 Total correct trials
Standard Deviation 12.0
|
-1.2 Total correct trials
Standard Deviation 11.1
|
5.3 Total correct trials
Standard Deviation 21.6
|
-5.7 Total correct trials
Standard Deviation 9.6
|
-6.9 Total correct trials
Standard Deviation 9.2
|
SECONDARY outcome
Timeframe: 0-5 hoursPopulation: Represents study completers
Behavioral task performance will be assessed with the DRUID app's Global impairment score (range 0-100), where lower scores indicate better performance.
Outcome measures
| Measure |
Active Cannabis Without Nicotine
n=20 Participants
Smoked cannabis containing active THC + No nicotine/tobacco
Cannabis: Cannabis will be smoked
|
Active Cannabis With Own Brand Cigarettes
n=20 Participants
Smoked cannabis containing active THC + ad-libitum use of preferred brand cigarettes
Cannabis: Cannabis will be smoked
Nicotine: Nicotine will be smoked or vaporized
|
Active Cannabis With Low Nicotine E-cigarette
n=20 Participants
Smoked cannabis containing active THC + ad-libitum use of low nicotine content E-Cig (3% nicotine JUUL)
Cannabis: Cannabis will be smoked
Nicotine: Nicotine will be smoked or vaporized
|
Active Cannabis With High Nicotine E-cigarette
n=20 Participants
Smoked cannabis containing active THC + ad-libitum use of high nicotine content E-Cig (5% nicotine JUUL)
Cannabis: Cannabis will be smoked
Nicotine: Nicotine will be smoked or vaporized
|
Placebo Cannabis With Own Brand Cigarettes
n=20 Participants
Smoked placebo cannabis + ad-libitum use of preferred brand cigarettes
Cannabis: Cannabis will be smoked
Nicotine: Nicotine will be smoked or vaporized
|
Placebo Cannabis With Low Nicotine E-cigarette
n=20 Participants
Smoked placebo cannabis + ad-libitum use of low nicotine content E-Cig (3% nicotine JUUL)
Cannabis: Cannabis will be smoked
Nicotine: Nicotine will be smoked or vaporized
|
Placebo Cannabis With High Nicotine E-cigarette
n=20 Participants
Smoked placebo cannabis + ad-libitum use of high nicotine content E-Cig (5% nicotine JUUL)
Cannabis: Cannabis will be smoked
Nicotine: Nicotine will be smoked or vaporized
|
|---|---|---|---|---|---|---|---|
|
Mean Peak Change From Baseline Behavioral Task Performance as Assessed by the DRUID App
|
4.3 score on a scale
Standard Deviation 12.0
|
-0.3 score on a scale
Standard Deviation 7.4
|
3.0 score on a scale
Standard Deviation 7.4
|
2.1 score on a scale
Standard Deviation 6.4
|
-1.3 score on a scale
Standard Deviation 10.3
|
-4.8 score on a scale
Standard Deviation 13.6
|
0.3 score on a scale
Standard Deviation 6.7
|
SECONDARY outcome
Timeframe: 0-5 hoursPopulation: Represents study completers
Mean peak change from baseline rating (0-100) of "Craving" with 0 being no craving and 100 being maximum craving.
Outcome measures
| Measure |
Active Cannabis Without Nicotine
n=20 Participants
Smoked cannabis containing active THC + No nicotine/tobacco
Cannabis: Cannabis will be smoked
|
Active Cannabis With Own Brand Cigarettes
n=20 Participants
Smoked cannabis containing active THC + ad-libitum use of preferred brand cigarettes
Cannabis: Cannabis will be smoked
Nicotine: Nicotine will be smoked or vaporized
|
Active Cannabis With Low Nicotine E-cigarette
n=20 Participants
Smoked cannabis containing active THC + ad-libitum use of low nicotine content E-Cig (3% nicotine JUUL)
Cannabis: Cannabis will be smoked
Nicotine: Nicotine will be smoked or vaporized
|
Active Cannabis With High Nicotine E-cigarette
n=20 Participants
Smoked cannabis containing active THC + ad-libitum use of high nicotine content E-Cig (5% nicotine JUUL)
Cannabis: Cannabis will be smoked
Nicotine: Nicotine will be smoked or vaporized
|
Placebo Cannabis With Own Brand Cigarettes
n=20 Participants
Smoked placebo cannabis + ad-libitum use of preferred brand cigarettes
Cannabis: Cannabis will be smoked
Nicotine: Nicotine will be smoked or vaporized
|
Placebo Cannabis With Low Nicotine E-cigarette
n=20 Participants
Smoked placebo cannabis + ad-libitum use of low nicotine content E-Cig (3% nicotine JUUL)
Cannabis: Cannabis will be smoked
Nicotine: Nicotine will be smoked or vaporized
|
Placebo Cannabis With High Nicotine E-cigarette
n=20 Participants
Smoked placebo cannabis + ad-libitum use of high nicotine content E-Cig (5% nicotine JUUL)
Cannabis: Cannabis will be smoked
Nicotine: Nicotine will be smoked or vaporized
|
|---|---|---|---|---|---|---|---|
|
Mean Peak Change From Baseline Tobacco Craving as Assessed by the Tobacco Craving Questionnaire
|
0.6 score on a scale
Standard Deviation 2.6
|
-0.8 score on a scale
Standard Deviation 2.4
|
0.0 score on a scale
Standard Deviation 2.7
|
-0.2 score on a scale
Standard Deviation 3.0
|
-0.2 score on a scale
Standard Deviation 2.3
|
0.6 score on a scale
Standard Deviation 1.8
|
0.8 score on a scale
Standard Deviation 3.2
|
SECONDARY outcome
Timeframe: 0-5 hoursPopulation: Represents study completers
Mean peak change from baseline rating (0-100) of "Craving" with 0 being no craving and 100 being maximum craving
Outcome measures
| Measure |
Active Cannabis Without Nicotine
n=20 Participants
Smoked cannabis containing active THC + No nicotine/tobacco
Cannabis: Cannabis will be smoked
|
Active Cannabis With Own Brand Cigarettes
n=20 Participants
Smoked cannabis containing active THC + ad-libitum use of preferred brand cigarettes
Cannabis: Cannabis will be smoked
Nicotine: Nicotine will be smoked or vaporized
|
Active Cannabis With Low Nicotine E-cigarette
n=20 Participants
Smoked cannabis containing active THC + ad-libitum use of low nicotine content E-Cig (3% nicotine JUUL)
Cannabis: Cannabis will be smoked
Nicotine: Nicotine will be smoked or vaporized
|
Active Cannabis With High Nicotine E-cigarette
n=20 Participants
Smoked cannabis containing active THC + ad-libitum use of high nicotine content E-Cig (5% nicotine JUUL)
Cannabis: Cannabis will be smoked
Nicotine: Nicotine will be smoked or vaporized
|
Placebo Cannabis With Own Brand Cigarettes
n=20 Participants
Smoked placebo cannabis + ad-libitum use of preferred brand cigarettes
Cannabis: Cannabis will be smoked
Nicotine: Nicotine will be smoked or vaporized
|
Placebo Cannabis With Low Nicotine E-cigarette
n=20 Participants
Smoked placebo cannabis + ad-libitum use of low nicotine content E-Cig (3% nicotine JUUL)
Cannabis: Cannabis will be smoked
Nicotine: Nicotine will be smoked or vaporized
|
Placebo Cannabis With High Nicotine E-cigarette
n=20 Participants
Smoked placebo cannabis + ad-libitum use of high nicotine content E-Cig (5% nicotine JUUL)
Cannabis: Cannabis will be smoked
Nicotine: Nicotine will be smoked or vaporized
|
|---|---|---|---|---|---|---|---|
|
Mean Peak Change From Baseline Cannabis Craving as Assessed by the Cannabis Craving Questionnaire
|
-1.9 score on a scale
Standard Deviation 2.5
|
-1.6 score on a scale
Standard Deviation 2.2
|
-1.7 score on a scale
Standard Deviation 2.6
|
-2.6 score on a scale
Standard Deviation 1.7
|
-1.0 score on a scale
Standard Deviation 2.1
|
-0.9 score on a scale
Standard Deviation 1.5
|
-0.9 score on a scale
Standard Deviation 2.4
|
Adverse Events
Active Cannabis Without Nicotine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Active Cannabis With Own Brand Cigarettes
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Active Cannabis With Low Nicotine E-cigarette
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Active Cannabis With High Nicotine E-cigarette
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo Cannabis With Own Brand Cigarettes
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Placebo Cannabis With Low Nicotine E-cigarette
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo Cannabis With High Nicotine E-cigarette
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Active Cannabis Without Nicotine
n=23 participants at risk
Smoked cannabis containing 10mg THC + No nicotine/tobacco
Cannabis: Cannabis will be smoked
|
Active Cannabis With Own Brand Cigarettes
n=20 participants at risk
Smoked cannabis containing 10mg THC + ad-libitum use of preferred brand cigarettes
Cannabis: Cannabis will be smoked
Nicotine: Nicotine will be smoked or vaporized
|
Active Cannabis With Low Nicotine E-cigarette
n=24 participants at risk
Smoked cannabis containing 10mg THC + ad-libitum use of low nicotine content E-Cig (3% nicotine JUUL)
Cannabis: Cannabis will be smoked
Nicotine: Nicotine will be smoked or vaporized
|
Active Cannabis With High Nicotine E-cigarette
n=22 participants at risk
Smoked cannabis containing 10mg THC + ad-libitum use of high nicotine content E-Cig (5% nicotine JUUL)
Cannabis: Cannabis will be smoked
Nicotine: Nicotine will be smoked or vaporized
|
Placebo Cannabis With Own Brand Cigarettes
n=21 participants at risk
Smoked placebo cannabis + ad-libitum use of preferred brand cigarettes
Cannabis: Cannabis will be smoked
Nicotine: Nicotine will be smoked or vaporized
|
Placebo Cannabis With Low Nicotine E-cigarette
n=22 participants at risk
Smoked placebo cannabis + ad-libitum use of low nicotine content E-Cig (3% nicotine JUUL)
Cannabis: Cannabis will be smoked
Nicotine: Nicotine will be smoked or vaporized
|
Placebo Cannabis With High Nicotine E-cigarette
n=21 participants at risk
Smoked placebo cannabis + ad-libitum use of high nicotine content E-Cig (5% nicotine JUUL)
Cannabis: Cannabis will be smoked
Nicotine: Nicotine will be smoked or vaporized
|
|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Vomitting
|
0.00%
0/23 • 0-5 hours
International Council for Harmonization (ICH) guidelines are followed for Adverse Event (AE) reporting, as AEs occur they are documented.
|
0.00%
0/20 • 0-5 hours
International Council for Harmonization (ICH) guidelines are followed for Adverse Event (AE) reporting, as AEs occur they are documented.
|
4.2%
1/24 • Number of events 1 • 0-5 hours
International Council for Harmonization (ICH) guidelines are followed for Adverse Event (AE) reporting, as AEs occur they are documented.
|
0.00%
0/22 • 0-5 hours
International Council for Harmonization (ICH) guidelines are followed for Adverse Event (AE) reporting, as AEs occur they are documented.
|
4.8%
1/21 • Number of events 1 • 0-5 hours
International Council for Harmonization (ICH) guidelines are followed for Adverse Event (AE) reporting, as AEs occur they are documented.
|
0.00%
0/22 • 0-5 hours
International Council for Harmonization (ICH) guidelines are followed for Adverse Event (AE) reporting, as AEs occur they are documented.
|
0.00%
0/21 • 0-5 hours
International Council for Harmonization (ICH) guidelines are followed for Adverse Event (AE) reporting, as AEs occur they are documented.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place