Table 1: Comparison of demographic and medical characteristics of the two study
groups in the ITT population
Diclectin
Placebo
P-Value
(n-131)
(n=125)
0.48
Ethnicity:
53 (40.5%)
56 (44.8 %)
Hispanic or Latino
78 (59.5%)
69 (55.2 %)
Not Hispanic or Latino
Race:
0.59
Asian
2 (1.5%)
1 (0.8%)
Black or African American 49 (37.4%)
48 (38.4 %)
White or Caucasian
80 (61.1%)
73 (58.4 %)
Unknown
3 (2.4%)
Previous Pregnancy
101 (77.1%)
94 (75.2 %)
0.64
Smoking during pregnancy 17 (13.0%)
16 (12.8 %)
0.97
Maternal Age (yr)
25.96
25.05.7
0.23
Weight (kg)
(lbs)
74.1022.30
163.3549.17
75.9122.19
167.3448.91
0.50
0.50
BMI (kg/m²):
Underweight
Normal
Overweight
Obese
BMI (kg/m²)
MeanSD
Median
Gestational age at start
of NVP (weeks)
MeanSD
0.42
5 (3.8%)
39 (29.8%)
31 (23.7%)
55 (42.0%)
0.95
28.777.60
27.97
29.6711.20
26.83
0.90
5.51.8
Gestational age at enrollment
(weeks)
MeanSD
9.32.0
PUQE score at Enrollment
MeanSD
Median
4 (3.2%)
38 (30.4%)
40 (32.0%)
42 (33.6%)
5.41.7
0.75
9.31.8
0.44
9.02.1
9.0
8.82.1
8.0
Global Assessment of Well
Being
MeanSD
5.02.3
5.42.2
Median
5.0
5.0
Table 2 Overall Summary of Tolerability/Adverse Events for ITT-S Subjects
______________________________________________________________________________
____Treatment Group____
Diclectin
(N=131)
Placebo
(N=127)
P-value1
Measure of Tolerability
______________________________________________________________________________
Number of Subjects with at least one treatment- 74 (56.5%)
65 (51.2%)
0.393
emergent AE
Number of Subjects with a serious treatment4 (3.1%)
4 (3.1%)
emergent AE
Number of Subjects with at least one Related AE
40 (30.5%)
32 (25.2%)
Number of Subjects discontinuing study drug due to AE 6 (4.6%)
4 (3.1%)
Number of deaths
0
0
Overall treatment0emergent AEs
Number of Subjects with at least one Mild AE
62 (47.3%)
59 (46.5%)
Number of Subjects with at least one Moderate AE
5 (3.8%)
1 (0.8%)
Number of Subjects with at least one Severe AE
7 (5.3%)
5 (3.9%)
Number of Subjects with Unrelated AE
34 (26.0%)
33 (26.0%)
Number of Subjects with at least one Possibly
24 (18.3%)
23 (18.1%)
Related AE
Number of Subjects with at least one Probably
13 (9.9%)
8 (6.3%)
Related AE
Number of Subjects with at least on Definitely
3 (2.3%
1 (0.8%)
Related AE
1.0002
0.339
0.7492
_
0.221
0.2152
0.711
0.570
0.714
0.388
0.6232
______________________________________________________________________________
1
The p-value for comparing Treatment groups uses Chi-square test method.
P-value is calculated using Fisher’s exact test method.
Related category includes Possible, Probable, and Definite relationships. Unrelated category includes
unlikely and not related.
Subjects reporting more than one AE will only be counted under the strongest relationship and/or
severity.
2
Table 3 Treatment Emergent Adverse Events (TEAEs) in the Study for ITT-S Subjects
______________________________________________________________________________
System Organ Class (SOC)
Preferred Term
P-value1
Diclectin
(N=131)
Treatment Group___
Placebo
(N=127)
______________________________________________________________________________
# of Subjects with at least one TEAE
74 (56.5%)
65 (51.2%)
0.39
Cardiac disorders
Palpitations
Eye disorders
Dry eye
Gastrointestinal disorders
Constipation
Dry mouth
Haematemesis
Feeling jittery
Laboratory Investigations
Alanine aminotransferase increased
Aspartate aminotransferase increased
Blood albumin decreased
Blood amylase increased
Blood chloride decreased
Blood creatinine increased
Blood lactate dehydrogenase increased
Blood sodium decreased
Blood triglycerides increased
Gamma-glutamyltransferase increased
Heart rate increased
Platelet count decreased
Nervous system disorders
Dizziness
Headache
Loss of consciousness
Poor quality sleep
Somnolence
Syncope
Fatigue
1 (0.8%)
1 (0.8%)
1 (0.8%)
1 (0.8%)
23 (17.6%)
2 (1.5%)
4 (3.1%)
0
1 (0.8%)
7 (5.3%)
0
0
1 (0.8%)
2 (1.5%)
0
1 (0.8%)
1 (0.8%)
0
1 (0.8%)
1 (0.8%)
0
1 (0.8%)
42 (32.1%)
8 (6.1%)
17 (13.0%)
0
1 (0.8%)
19 (14.5%)
1 (0.8%)
9 (6.9%)
1 (0.8%)
1 (0.8%)
0
0
22 (17.3%)
2 (1.6%)
1 (0.8%)
1 (0.8%)
0
6 (4.7%)
1 (0.8%)
1 (0.8%)
0.4922
0
2 (1.6%)
1 (0.8%)
1 (0.8%)
0
1 (0.8%)
0
1 (0.8%)
1 (0.8%)
0
37 (29.1%)
8 (6.3%)
20 (15.7%)
1 (0.8%)
0
15 (11.8%)
1 (0.8%)
8 (6.3%)
1.0002
1.0002
1.0002
1.0002
0.960
1.0002
0.3702
0.4922
1.0002
0.820
0.4922
1.0002
1.0002
0.4922
1.0002
1.0002
0.4922
1.0002
1.0002
0.4922
1.0002
0.610
0.949
0.526
0.4922
1.0002
0.523
1.0002
0.853
______________________________________________________________________________
1
The p-value for comparing Treatment groups uses Chi-square test method.
P-value is calculated using Fisher’s exact test method.
At each level of summarization (SOC/preferred term), subjects reporting more than one AE will only be
counted once.
2
Table 4 Most Frequently Occurring Treatment Emergent Adverse Events (TEAEs) in the
Study for ITT-S Subjects
______________________________________________________________________________
System Organ Class (SOC)
Diclectin
Treatment Group___
Placebo
Preferred Term
P-value1
(N=131)
(N=127)
______________________________________________________________________________
# of Subjects with at least one TEAE
Gastrointestinal disorders
Abdominal pain
General disorders and administration site
Conditions
Fatigue
Musculoskeletal and connective tissue
Disorders
Back pain
Nervous system disorders
Dizziness
Headache
Somnolence
74 (56.5%)
23 (17.6%)
5 (3.8%)
13 (9.9%)
65 (51.2%)
22 (17.3%)
8 (6.3%)
12 (9.4%)
0.393
0.960
0.362
0.897
9 (6.9%)
11 (8.4%)
8 (6.3%)
4 (3.1%)
0.949
0.072
7 (5.3%)
42 (32.1%)
8 (6.1%)
17 (13.0%)
19 (14.5%)
4 (3.1%)
37 (29.1%)
8 (6.3%)
20 (15.7%)
15 (11.8%)
0.383
0.610
0.949
0.526
0.523
______________________________________________________________________________
1
The p-value for comparing Treatment groups uses Chi-square test method.
P-value is calculated using Fisher’s exact test method.
TEAEs that are considered most frequently occurring include the events (in preferred terms) reported by
at least 5% of subjects in any of the treatment groups.
At each level of summarization (SOC/preferred term), subjects reporting more than one AE will only be
counted once.
2
Table 5 Treatment Emergent Adverse Events (TEAEs) with Respect to Relationship to Study
DrugRelated vs. Unrelated for ITT-S Subjects
______________________________________________________________________________
Treatment Group__________
Diclectin
Placebo
(N=131)
(N=127)
__________________________________
System Organ Class (SOC)
Preferred Term
Related
Unrelated
Related
Unrelated
______________________________________________________________________________
# of Subjects with at least one
TEAE in the study
Cardiac disorders
Palpitations
Eye disorders
Dry eye
Gastrointestinal disorders
Abdominal pain
40 (30.5%)
34 (26.0%)
32 (25.2%)
1 (0.8%)
1 (0.8%)
0
0
8 (6.1%)
1 (0.8%)
0
0
1 (0.8%)
1 (0.8%)
15 (11.5%)
4 (3.1%)
0
0
0
0
8 (6.3%)
3 (2.4%)
33 (26.0%)
1 (0.8%)
1 (0.8%)
0
0
14 (11.0%)
5 (3.9%)
Abdominal pain upper
Constipation
Diarrhea
Dry mouth
Dyspepsia
Flatulence
Salivary hypersecretion
General disorders and administration
Feeling jittery
Nervous system disorders
Dizziness
Headache
Loss of consciousness
Poor quality sleep
Somnolence
Syncope
Fatigue
0
1 (0.8%)
2 (1.5%)
4 (3.1%)
1 (0.8%)
0
0
7 (5.3%)
1 (0.8%)
33 (25.2%)
6 (4.6%)
8 (6.1%)
0
0
19 (14.5%)
1 (0.8%)
6 (4.6%)
3 (2.3%)
1 (0.8%)
2 (1.5%)
0
4 (3.1%)
0
0
6 (4.6%)
0
9 (6.9%)
2 (1.5%)
9 (6.9%)
0
1 (0.8%)
0
0
3 (2.3%)
2 (1.6%)
1 (0.8%)
1 (0.8%)
1 (0.8%)
1 (0.8%)
0
0
6 (4.7%)
0
24 (18.9%)
5 (3.9%)
8 (6.3%)
0
0
15 (11.8%)
0
5 (3.9%)
3 (2.4%)
1 (0.8%)
1 (0.8%)
0
1 (0.8%)
1 (0.8%)
1 (0.8%)
6 (4.7%)
0
13 (10.2%)
3 (2.4%)
12 (9.4%)
1 (0.8%)
0
0
1 (0.8%)
3 (2.4%)
______________________________________________________________________________
Related category includes Possible, Probable, and Definite relationships. Unrelated category includes
unlikely and not related.
At each level of summarization (SOC/preferred term), subjects reporting more than on AE will only be
counted once under the strongest relationship.