Versions Compared

Old Version 34

changes.mady.by.user Kathleen Mellars

Saved on

compared with

New Version 35

changes.mady.by.user Jon Neville

Saved on

Key

  • This line was added.
  • This line was removed.
  • Formatting was changed.

This is a study where subjects were randomized to 3 different concentrations of Nicotine e-nicotine liquid, or their usual brand of cigarettes. The subject used the product at home for 2 weeks. This 2-week period allowed subjects to become familiar with the e-cigarette. After two weeks, the subjects were confined to the clinical for one day. They were required to not use any tobacco products for 12 hours prior to the visit. Subjects had to have CO level below a pre-specified level, to attend the visit. If the level, was too high, the visit was re-scheduled. Subjects were instructed to take 10 puffs on the e-cigarette/usual brand of cigarettes in the morning and afternoon. Puff topography was measured in the morning and afternoon using the same device for all subjects. Subjects were not allowed to use any tobacco products between the morning and afternoon sessions. 

...

Dataset wrap
Nameex
Dataset2
RowSTUDYIDDOMAINUSUBJIDSPTOBIDEXSEQEXLNKIDEXTRTEXDOSEEXDOSTXTEXDOSUEXDOSFRMEXROUTEEXPSTRGEXPSTRGUEXSTDTCEXENDTC
1TOPT001EX3001EC-3331
Nicotine e-nicotine liquid
AD LIBITUM
CARTRIDGERESPIRATORY (INHALATION)8mg/mL2020-06-262020-07-14
2TOPT001EX3001EC-33321Nicotine e-nicotine liquid10
PUFFCARTRIDGERESPIRATORY (INHALATION)8mg/mL2020-07-15T9:002020-07-15TT9:45
3TOPT001EX3001EC-33332Nicotine e-nicotine liquid10
PUFFCARTRIDGERESPIRATORY (INHALATION)8mg/mL2020-07-15T3:002020-07-15TT3:45
4TOPT001EX4001EC-3331
Nicotine e-nicotine liquid
AD LIBITUM
CARTRIDGERESPIRATORY (INHALATION)16mg/mL2020-09-062020-09-22
5TOPT001EX4001EC-33321Nicotine e-nicotine liquid10
PUFFCARTRIDGERESPIRATORY (INHALATION)16mg/mL2020-09-22T9:002020-09-22T9:30
6TOPT001EX4001EC-33332Nicotine e-nicotine liquid10
PUFFCARTRIDGERESPIRATORY (INHALATION)16mg/mL2020-09-22T3:002020-09-22T3:30
7TOPT001EX5004
1
Cigarettes Brand XYZ
AD LIBITUM
CIGARETTERESPIRATORY (INHALATION)12.1mg/cigarette2020-10-082020-10-22
8TOPT001EX5004
21Cigarettes Brand XYZ10
PUFFCIGARETTERESPIRATORY (INHALATION)12.1mg/cigarette2020-10-22T9:002020-09-22T9:30
9TOPT0011EX5004
32Cigarettes Brand XYZ10
PUFFCIGARETTERESPIRATORY (INHALATION)12.1mg/cigarette2020-10-22T3:002020-09-22T3:30

...

Dataset wrap
Namefaex
Rowcaps
Rows 1, 6:Show the Number of Puffs taken in the time interval specified in FADTC and FAENDTC. This was pre-specified in the design, but the sponsor reported the actual number of puffs taken.  
Rows 2-5:Show the various measurements recorded for subject 3001 for Puff 1 during the morning administration of the tobacco product. FADTC and FAENDTC provide the timing of each puff. The individual puff data for the afternoon are not shown. 
Rows 6-10:Show the various measurements recorded for subject 3001 for Puff 10 during the afternoon administration of the tobacco product. FADTC and FAENDTC provide the timing of each puff. The individual puff data for the morning session are not shown. Note the data for Puffs  2-9 are not shown to save spacesimplify dataset review.  
Rows 12-15:  Show the various measurements recorded for subject 4001. Only a few rows are shown to save spacesimplify dataset review.      
Dataset2
RowSTUDYIDDOMAINUSUBJIDSPDEVIDSPTOBIDFASEQFALNKIDFASPIDFATESTCDFATESTFAOBJFACATFAORRESFAORRESUFASTRESCFASTRESUVISITNUMFADTCFAENDTCFATPT
1TOPT001FA3001PUFANYXYZEC-33311
PUFF TOTTotal Number of PuffsNicotine e-nicotine liquid

PUFF TOPOGRAPHY

10PUFFS10PUFFS22020-07-15T09:002020-07-15TT9:45

AM

2TOPT001FA3001PUFANYXYZEC-33321PUFF 1PUFFVOLPuff VolumeNicotine e-nicotine liquid

PUFF TOPOGRAPHY

36.7mL/sec37mL/sec2

2020-07-15T09:01.36

2020-07-15T09:01.38

AM

3

TOPT001

FA3001PUFANYXYZEC-33331PUFF 1AVGFLOWAverage Flow rateNicotine e-nicotine liquidPUFF TOPOGRAPHY15.5mL/sec15.5mL/sec22020-07-15T09:01.362020-07-15T09:01.38AM
4TOPT001FA3001PUFANYXYZEC-33341PUFF 1PKFLOWPeak Flow RateNicotine e-nicotine liquidPUFF TOPOGRAPHY20.5mL/sec20.5mL/sec22020-07-15T09:01.362020-07-15T09:01.38AM
5TOPT001FA3001PUFANYXYZEC-33351PUFF 1PUFFDURPuff DurationNicotine e-nicotine liquidPUFF TOPOGRAPHY2.0msec1.6msec22020-07-15T09:01.362020-07-15T09:01.38AM
6

TOPT001

FA3001PUFANYXYZEC-33362
PUFF TOTTotal Number of Puffse-nicotin liquid

PUFF TOPOGRAPHY

9PUFFS9PUFFS22020-07-15T03:002020-07-15T03:30PM
7TOPT001FA3001PUFANYXYZEC-33372PUFF 10INTPUFINPuff IntervalNicotine e-nicotine liquidPUFF TOPOGRAPHY910396.8sec910396.8sec22020-07-15T03:30:342020-07-15T03:30:36PM
8TOPT001FA3001PUFANYXYZEC-33382PUFF 10PUFFVOLPuff VolumeNicotine e-nicotine liquidPUFF TOPOGRAPHY43mL/sec43mL/sec22020-07-15T03:30:342020-07-15T03:30:36

PM

9

TOPT001

FA3001PUFANYXYZEC-33392PUFF 10AVGFLOWAverage Flow rateNicotine e-nicotine liquidPUFF TOPOGRAPHY14.5mL/sec14.5mL/sec22020-07-15T03:30:342020-07-15T03:30:36

PM

10TOPT001FA3001PUFANYXYZEC-333102PUFF 10PKFLOWPeak Flow RateNicotine e-nicotine liquidPUFF TOPOGRAPHY22.5mL/sec22.5mL/sec22020-07-15T03:30:342020-07-15T03:30:36

PM

12TOPT001FA4001PUFANYXYZEC-33311
PUFF TOTTotal Number of PuffsNicotine e-nicotine liquid

PUFF TOPOGRAPHY

10PUFFS10PUFFS22020-08-15T9:002020-08-15TT9:45

AM

13

TOPT001

FA4001PUFANYXYZEC-33321PUFF 1PUFFVOLPuff VolumeNicotine e-nicotine liquidPUFF TOPOGRAPHY34.7mL/sec34mL/sec22020-08-15T09:01.362020-08-15T09:01.38AM
14TOPT001FA4001PUFANYXYZEC-33331PUFF 1AVGFLOWAverage Flow rateNicotine e-nicotine liquidPUFF TOPOGRAPHY15.5mL/sec15.5mL/sec22020-08-15T09:01.362020-08-15T09:01.38AM
15TOPT001FA4001PUFANYXYZEC-33341PUFF 1PKFLOWPeak Flow RateNicotine e-nicotine liquidPUFF TOPOGRAPHY23.5mL/sec23.5mL/sec22020-08-15T09:01.362020-08-15T09:01.38AM



...