Trial Outcomes & Findings for Phase III Study Comparing Efficacy and Safety of AFOLIA vs Gonal-f® RFF in Women (35 to 42) Undergoing IVF (NCT NCT01687712)
NCT ID: NCT01687712
Last Updated: 2017-12-05
Results Overview
Clinical pregnancy was defined as presence of at least one intrauterine gestational sac and fetal heart activity as demonstrated by vaginal ultrasound at six weeks (42 +/- 1 day) post ET (Visit 11). The clinical pregnancy rate is the proportion of subjects who achieve clinical pregnancy, relative to the number of patients in the ITT population of the respective treatment arm.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1100 participants
Primary outcome timeframe
Six weeks post embryo transfer
Results posted on
2017-12-05
Participant Flow
1548 subjects were enrolled, 1101 subjects were randomized and 1100 received Investigational Medicinal Product (IMP) at 22 investigational sites in the United States.
After the informed consent was signed, each subject received a subject identification number and underwent the down-regulation procedure. After a successful downregulation, subjects were centrally randomized in a 1:1 ratio to one of the treatment groups, AFOLIA or Gonal-f®RFF.
Participant milestones
| Measure |
AFOLIA
One subcutaneous injection of 225IU AFOLIA (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU.
|
Gonal-f® RFF
One subcutaneous injection of 225IU Gonal-f® RFF (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU.
|
|---|---|---|
|
Cycle 1
STARTED
|
549
|
551
|
|
Cycle 1
Received hCG
|
516
|
520
|
|
Cycle 1
Oocyte/Ovum Pick Up
|
513
|
517
|
|
Cycle 1
Fertilization Performed
|
508
|
512
|
|
Cycle 1
Embryo Transfer
|
466
|
483
|
|
Cycle 1
Biochemical Pregnancy
|
163
|
203
|
|
Cycle 1
Clinical Pregnancy
|
114
|
138
|
|
Cycle 1
COMPLETED
|
101
|
122
|
|
Cycle 1
NOT COMPLETED
|
448
|
429
|
|
Cycle 2
STARTED
|
109
|
120
|
|
Cycle 2
Received hCG
|
107
|
119
|
|
Cycle 2
Oocyte/Ovum Pick Up
|
107
|
119
|
|
Cycle 2
Fertilization Performed
|
106
|
119
|
|
Cycle 2
Embryo Transfer
|
101
|
117
|
|
Cycle 2
Biochemical Pregnancy
|
35
|
43
|
|
Cycle 2
Clinical Pregnancy
|
17
|
26
|
|
Cycle 2
COMPLETED
|
16
|
25
|
|
Cycle 2
NOT COMPLETED
|
93
|
95
|
|
Cycle 3
STARTED
|
28
|
24
|
|
Cycle 3
Received hCG
|
27
|
24
|
|
Cycle 3
Ooctye/Ovum Pick-Up
|
27
|
24
|
|
Cycle 3
Fertilization Performed
|
27
|
24
|
|
Cycle 3
Embryo Transfer
|
26
|
24
|
|
Cycle 3
Biochemically Pregnant
|
7
|
2
|
|
Cycle 3
Clinical Pregnancy
|
5
|
0
|
|
Cycle 3
COMPLETED
|
4
|
0
|
|
Cycle 3
NOT COMPLETED
|
24
|
24
|
Reasons for withdrawal
| Measure |
AFOLIA
One subcutaneous injection of 225IU AFOLIA (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU.
|
Gonal-f® RFF
One subcutaneous injection of 225IU Gonal-f® RFF (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU.
|
|---|---|---|
|
Cycle 1
Not Biochemically Pregnant
|
386
|
348
|
|
Cycle 1
Early Pregnancy Loss
|
43
|
60
|
|
Cycle 1
Ectopic Pregnancy
|
5
|
5
|
|
Cycle 1
Heterotropic Pregnancy
|
1
|
0
|
|
Cycle 1
Miscarriage/Spontaneous Abortion
|
9
|
14
|
|
Cycle 1
Abortion
|
3
|
0
|
|
Cycle 1
Intrauterine Fetal Death
|
0
|
1
|
|
Cycle 1
Lost to Follow-up
|
1
|
1
|
|
Cycle 2
Not Biochemically Pregnant
|
74
|
77
|
|
Cycle 2
Early Pregnancy Loss
|
18
|
16
|
|
Cycle 2
Ectopic Pregnancy
|
0
|
1
|
|
Cycle 2
Still Birth
|
1
|
0
|
|
Cycle 2
Miscarriage/Spontaneous Abortion
|
0
|
1
|
|
Cycle 3
Not Biochemically Pregnant
|
21
|
22
|
|
Cycle 3
Early Pregnancy Loss
|
1
|
2
|
|
Cycle 3
Ectopic Pregnancy
|
1
|
0
|
|
Cycle 3
Miscarriage/Spontaneous Abortion
|
1
|
0
|
Baseline Characteristics
Number of subjects analysed is less than the number of subjects in the ITT population due to missing data.
Baseline characteristics by cohort
| Measure |
AFOLIA
n=549 Participants
One subcutaneous injection of 225IU AFOLIA (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU.
|
Gonal-f® RFF
n=551 Participants
One subcutaneous injection of 225IU Gonal-f® RFF (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU.
|
Total
n=1100 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
37.7 years
STANDARD_DEVIATION 2.16 • n=549 Participants
|
37.8 years
STANDARD_DEVIATION 2.18 • n=551 Participants
|
37.8 years
STANDARD_DEVIATION 2.17 • n=1100 Participants
|
|
Age, Customized
35-37
|
275 Participants
n=549 Participants
|
276 Participants
n=551 Participants
|
551 Participants
n=1100 Participants
|
|
Age, Customized
38-40
|
201 Participants
n=549 Participants
|
194 Participants
n=551 Participants
|
395 Participants
n=1100 Participants
|
|
Age, Customized
41-42
|
73 Participants
n=549 Participants
|
81 Participants
n=551 Participants
|
154 Participants
n=1100 Participants
|
|
Sex: Female, Male
Female
|
549 Participants
n=549 Participants
|
551 Participants
n=551 Participants
|
1100 Participants
n=1100 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=549 Participants
|
0 Participants
n=551 Participants
|
0 Participants
n=1100 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
96 Participants
n=549 Participants
|
78 Participants
n=551 Participants
|
174 Participants
n=1100 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
452 Participants
n=549 Participants
|
473 Participants
n=551 Participants
|
925 Participants
n=1100 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=549 Participants
|
0 Participants
n=551 Participants
|
1 Participants
n=1100 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
3 Participants
n=549 Participants
|
1 Participants
n=551 Participants
|
4 Participants
n=1100 Participants
|
|
Race (NIH/OMB)
Asian
|
40 Participants
n=549 Participants
|
48 Participants
n=551 Participants
|
88 Participants
n=1100 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=549 Participants
|
1 Participants
n=551 Participants
|
3 Participants
n=1100 Participants
|
|
Race (NIH/OMB)
Black or African American
|
61 Participants
n=549 Participants
|
57 Participants
n=551 Participants
|
118 Participants
n=1100 Participants
|
|
Race (NIH/OMB)
White
|
435 Participants
n=549 Participants
|
440 Participants
n=551 Participants
|
875 Participants
n=1100 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=549 Participants
|
0 Participants
n=551 Participants
|
0 Participants
n=1100 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=549 Participants
|
4 Participants
n=551 Participants
|
12 Participants
n=1100 Participants
|
|
Height (m)
|
1.643 meters
STANDARD_DEVIATION 0.0660 • n=549 Participants • Number of subjects analysed is less than the number of subjects in the ITT population due to missing data.
|
1.642 meters
STANDARD_DEVIATION 0.0684 • n=550 Participants • Number of subjects analysed is less than the number of subjects in the ITT population due to missing data.
|
1.642 meters
STANDARD_DEVIATION 0.0672 • n=1099 Participants • Number of subjects analysed is less than the number of subjects in the ITT population due to missing data.
|
|
Weight (kg)
|
70.01 kilograms
STANDARD_DEVIATION 13.803 • n=541 Participants • Number of subjects analysed is less than the number of subjects in the ITT population due to missing data.
|
71.12 kilograms
STANDARD_DEVIATION 13.844 • n=546 Participants • Number of subjects analysed is less than the number of subjects in the ITT population due to missing data.
|
70.57 kilograms
STANDARD_DEVIATION 13.828 • n=1087 Participants • Number of subjects analysed is less than the number of subjects in the ITT population due to missing data.
|
|
BMI (kg/m^2)
|
25.92 kg/m^2
STANDARD_DEVIATION 4.738 • n=541 Participants • Number of subjects analysed is less than the number of subjects in the ITT population due to missing data.
|
26.38 kg/m^2
STANDARD_DEVIATION 4.784 • n=545 Participants • Number of subjects analysed is less than the number of subjects in the ITT population due to missing data.
|
26.15 kg/m^2
STANDARD_DEVIATION 4.765 • n=1086 Participants • Number of subjects analysed is less than the number of subjects in the ITT population due to missing data.
|
|
BMI Category (kg/m^2)
>=18 to <25
|
279 Participants
n=549 Participants
|
245 Participants
n=551 Participants
|
524 Participants
n=1100 Participants
|
|
BMI Category (kg/m^2)
>=25 to <30
|
150 Participants
n=549 Participants
|
184 Participants
n=551 Participants
|
334 Participants
n=1100 Participants
|
|
BMI Category (kg/m^2)
>=30 to <=38
|
109 Participants
n=549 Participants
|
112 Participants
n=551 Participants
|
221 Participants
n=1100 Participants
|
|
BMI Category (kg/m^2)
>38
|
3 Participants
n=549 Participants
|
4 Participants
n=551 Participants
|
7 Participants
n=1100 Participants
|
|
BMI Category (kg/m^2)
Unknown or Not Reported
|
8 Participants
n=549 Participants
|
6 Participants
n=551 Participants
|
14 Participants
n=1100 Participants
|
|
Primary Cause of Infertility
Unexplained Infertility
|
225 Participants
n=549 Participants
|
206 Participants
n=551 Participants
|
431 Participants
n=1100 Participants
|
|
Primary Cause of Infertility
Male Factor
|
189 Participants
n=549 Participants
|
178 Participants
n=551 Participants
|
367 Participants
n=1100 Participants
|
|
Primary Cause of Infertility
Tubal Factor
|
138 Participants
n=549 Participants
|
169 Participants
n=551 Participants
|
307 Participants
n=1100 Participants
|
|
Primary Cause of Infertility
Mild Endometriosis
|
59 Participants
n=549 Participants
|
45 Participants
n=551 Participants
|
104 Participants
n=1100 Participants
|
|
Primary Cause of Infertility
Other
|
28 Participants
n=549 Participants
|
41 Participants
n=551 Participants
|
69 Participants
n=1100 Participants
|
|
Infertility Duration
|
4.1 years
STANDARD_DEVIATION 4.61 • n=548 Participants • Number of subjects analysed is less than the number of subjects in the ITT population due to missing data.
|
4.2 years
STANDARD_DEVIATION 4.54 • n=550 Participants • Number of subjects analysed is less than the number of subjects in the ITT population due to missing data.
|
4.1 years
STANDARD_DEVIATION 4.58 • n=1098 Participants • Number of subjects analysed is less than the number of subjects in the ITT population due to missing data.
|
|
Number of previous fresh ART cycles [N(%)]
0
|
441 Participants
n=549 Participants
|
440 Participants
n=551 Participants
|
881 Participants
n=1100 Participants
|
|
Number of previous fresh ART cycles [N(%)]
1
|
81 Participants
n=549 Participants
|
77 Participants
n=551 Participants
|
158 Participants
n=1100 Participants
|
|
Number of previous fresh ART cycles [N(%)]
2
|
20 Participants
n=549 Participants
|
30 Participants
n=551 Participants
|
50 Participants
n=1100 Participants
|
|
Number of previous fresh ART cycles [N(%)]
≥3
|
7 Participants
n=549 Participants
|
4 Participants
n=551 Participants
|
11 Participants
n=1100 Participants
|
|
FSH at screening
|
7.98 international units (IU)
STANDARD_DEVIATION 4.636 • n=548 Participants • Number of subjects analysed is less than the number of subjects in the ITT population due to missing data.
|
7.76 international units (IU)
STANDARD_DEVIATION 2.433 • n=550 Participants • Number of subjects analysed is less than the number of subjects in the ITT population due to missing data.
|
7.87 international units (IU)
STANDARD_DEVIATION 3.700 • n=1098 Participants • Number of subjects analysed is less than the number of subjects in the ITT population due to missing data.
|
|
LH at screening
|
5.77 international units (IU)
STANDARD_DEVIATION 3.36 • n=377 Participants • Number of subjects analysed is less than the number of subjects in the ITT population due to missing data.
|
5.74 international units (IU)
STANDARD_DEVIATION 2.44 • n=385 Participants • Number of subjects analysed is less than the number of subjects in the ITT population due to missing data.
|
5.76 international units (IU)
STANDARD_DEVIATION 2.93 • n=762 Participants • Number of subjects analysed is less than the number of subjects in the ITT population due to missing data.
|
PRIMARY outcome
Timeframe: Six weeks post embryo transferPopulation: Intention to treat population, defined as all randomized subjects who received at least one dose of study treatment, based on their randomization.
Clinical pregnancy was defined as presence of at least one intrauterine gestational sac and fetal heart activity as demonstrated by vaginal ultrasound at six weeks (42 +/- 1 day) post ET (Visit 11). The clinical pregnancy rate is the proportion of subjects who achieve clinical pregnancy, relative to the number of patients in the ITT population of the respective treatment arm.
Outcome measures
| Measure |
AFOLIA
n=549 Participants
One subcutaneous injection of 225IU AFOLIA (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU.
|
Gonal-f® RFF
n=551 Participants
One subcutaneous injection of 225IU Gonal-f® RFF (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU.
|
|---|---|---|
|
Clinical Pregnancy Rate After One Cycle of Treatment - ITT Population
Yes
|
114 Participants
|
138 Participants
|
|
Clinical Pregnancy Rate After One Cycle of Treatment - ITT Population
No
|
435 Participants
|
413 Participants
|
PRIMARY outcome
Timeframe: Six weeks post embryo transferPopulation: Per-protocol population, defined as a subset of the ITT population composed of all patients without any major protocol deviation (i.e. one which would affect the primary efficacy endpoint assessment).
Clinical pregnancy was defined as presence of at least one intrauterine gestational sac and fetal heart activity as demonstrated by vaginal ultrasound at six weeks (42 +/- 1 day) post ET (Visit 11). The clinical pregnancy rate is the proportion of subjects who achieve clinical pregnancy, relative to the number of patients in the PP population of the respective treatment arm.
Outcome measures
| Measure |
AFOLIA
n=486 Participants
One subcutaneous injection of 225IU AFOLIA (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU.
|
Gonal-f® RFF
n=494 Participants
One subcutaneous injection of 225IU Gonal-f® RFF (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU.
|
|---|---|---|
|
Clinical Pregnancy Rate After One Cycle of Treatment - PP Population
Yes
|
108 Participants
|
125 Participants
|
|
Clinical Pregnancy Rate After One Cycle of Treatment - PP Population
No
|
378 Participants
|
369 Participants
|
SECONDARY outcome
Timeframe: Measured at discretionary visits between Days 9 and 15 after FSH startsPopulation: Intention to treat population, defined as all randomized subjects who received at least one dose of study treatment, based on their randomization.
The number of days of r-hFSH stimulation a subject received during Cycle 1.
Outcome measures
| Measure |
AFOLIA
n=549 Participants
One subcutaneous injection of 225IU AFOLIA (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU.
|
Gonal-f® RFF
n=551 Participants
One subcutaneous injection of 225IU Gonal-f® RFF (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU.
|
|---|---|---|
|
Exposure to r-hFSH Injections: Days of r-hFSH Stimulation - Cycle 1
|
10.8 days
Standard Deviation 1.72
|
11.0 days
Standard Deviation 1.67
|
SECONDARY outcome
Timeframe: Measured at discretionary visits between Days 9 and 15 after FSH starts.Population: Intention to treat population, defined as all randomized subjects who received at least one dose of study treatment, based on their randomization.
The total dose of r-hFSH that subjects received during Cycle 1.
Outcome measures
| Measure |
AFOLIA
n=549 Participants
One subcutaneous injection of 225IU AFOLIA (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU.
|
Gonal-f® RFF
n=551 Participants
One subcutaneous injection of 225IU Gonal-f® RFF (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU.
|
|---|---|---|
|
Exposure to r-hFSH Injections: Total Dose of r-hFSH (IU) - Cycle 1
|
3209.2 international unit (IU)
Standard Deviation 1008.05
|
3343.6 international unit (IU)
Standard Deviation 1005.08
|
SECONDARY outcome
Timeframe: Measured at discretionary visits between Days 9 and 15 after FSH starts.Population: Intention to treat population, defined as all randomized subjects who received at least one dose of study treatment, based on their randomization.
The mean dose of r-hFSH that subjects received in a day during Cycle 1.
Outcome measures
| Measure |
AFOLIA
n=549 Participants
One subcutaneous injection of 225IU AFOLIA (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU.
|
Gonal-f® RFF
n=551 Participants
One subcutaneous injection of 225IU Gonal-f® RFF (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU.
|
|---|---|---|
|
Exposure to r-hFSH Injections: Daily Dose of r-hFSH (IU) - Cycle 1
|
292.1 international unit (IU)
Standard Deviation 57.90
|
297.5 international unit (IU)
Standard Deviation 56.97
|
SECONDARY outcome
Timeframe: Visit 8, 34-36 hours after hCG administrationPopulation: Intention to treat population, defined as all randomized subjects who received at least one dose of study treatment, based on their randomization.
The number of oocytes retrieved per subject, following hCG administration in Cycle 1.
Outcome measures
| Measure |
AFOLIA
n=513 Participants
One subcutaneous injection of 225IU AFOLIA (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU.
|
Gonal-f® RFF
n=517 Participants
One subcutaneous injection of 225IU Gonal-f® RFF (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU.
|
|---|---|---|
|
Number of Oocytes Retrieved - Cycle 1
|
11.3 Oocytes retrieved
Standard Deviation 6.76
|
11.2 Oocytes retrieved
Standard Deviation 6.63
|
SECONDARY outcome
Timeframe: Measure recorded in the Patient Diary which is maintained through entire FSH treatment, from FSH Start through to Day 16 after start of FSH (16 days).Population: Safety population, defined as all randomized subjects who received at least one dose of study treatment, based on their randomization.
Number of subjects reporting at least one dermal response to r-hFSH injection and number of subjects reporting no dermal responses.
Outcome measures
| Measure |
AFOLIA
n=549 Participants
One subcutaneous injection of 225IU AFOLIA (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU.
|
Gonal-f® RFF
n=551 Participants
One subcutaneous injection of 225IU Gonal-f® RFF (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU.
|
|---|---|---|
|
Local and Systemic Adverse Events: Dermal Response to Injection - Cycle 1
Subjects who reported at least one dermal response
|
37 Participants
|
42 Participants
|
|
Local and Systemic Adverse Events: Dermal Response to Injection - Cycle 1
Subjects who reported no dermal responses
|
512 Participants
|
509 Participants
|
SECONDARY outcome
Timeframe: Measure recorded in the Patient Diary which is maintained through entire FSH treatment, from FSH through to Day 16 after start of FSH (16 days).Population: Safety population, defined as all randomized subjects who received at least one dose of study treatment, based on their randomization.
Dermal response to r-hFSH injection as assessed by the investigator and categorized according to severity of reaction
Outcome measures
| Measure |
AFOLIA
n=549 Participants
One subcutaneous injection of 225IU AFOLIA (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU.
|
Gonal-f® RFF
n=551 Participants
One subcutaneous injection of 225IU Gonal-f® RFF (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU.
|
|---|---|---|
|
Local and Systemic Adverse Events: Dermal Response to Injection by Severity - Cycle 1
No evidence of irritation
|
28 Participants
|
25 Participants
|
|
Local and Systemic Adverse Events: Dermal Response to Injection by Severity - Cycle 1
Minimal erythema, barely perceptible
|
2 Participants
|
7 Participants
|
|
Local and Systemic Adverse Events: Dermal Response to Injection by Severity - Cycle 1
Definited Erythema, readily visible; minimal edema
|
0 Participants
|
1 Participants
|
|
Local and Systemic Adverse Events: Dermal Response to Injection by Severity - Cycle 1
Definite Edema
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Measured from the start of FSH treatment through to either the end FSH treatment + 30 days (up to 46 days) or to the last Telephone Follow-up / Live Birth Questionnaire on pregnancy outcome (if applicable) (up to 10 months).Population: Safety population, defined as all randomized subjects who received at least one dose of study treatment, based on their randomization.
Summary of AEs, including the number of subjects experiencing to following during Cycle 1: At least one AE At least one treatment related AE At least one serious AE At least one AE leading to discontinuation of study drug At least one AE due to pregnancy complication
Outcome measures
| Measure |
AFOLIA
n=549 Participants
One subcutaneous injection of 225IU AFOLIA (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU.
|
Gonal-f® RFF
n=551 Participants
One subcutaneous injection of 225IU Gonal-f® RFF (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU.
|
|---|---|---|
|
Overall Summary of Adverse Events (AEs) - Cycle 1
At least one AE
|
403 Participants
|
391 Participants
|
|
Overall Summary of Adverse Events (AEs) - Cycle 1
At least one treatment related AE
|
202 Participants
|
197 Participants
|
|
Overall Summary of Adverse Events (AEs) - Cycle 1
At least one serious adverse event
|
32 Participants
|
31 Participants
|
|
Overall Summary of Adverse Events (AEs) - Cycle 1
At least one AE leading to discontinuation
|
2 Participants
|
1 Participants
|
|
Overall Summary of Adverse Events (AEs) - Cycle 1
At least one AE due to pregnancy complication
|
29 Participants
|
30 Participants
|
SECONDARY outcome
Timeframe: Measured either 3 days after ooctye pick up (Visit 9) or 18 +/- 1 days after oocyte pick up (Visit 10).Population: Safety population, defined as all randomized subjects who received at least one dose of study treatment, based on their randomization.
Summary of the number of subjects with mild, moderate and severe OHSS. The total number of subjects with OHSS is also included.
Outcome measures
| Measure |
AFOLIA
n=549 Participants
One subcutaneous injection of 225IU AFOLIA (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU.
|
Gonal-f® RFF
n=551 Participants
One subcutaneous injection of 225IU Gonal-f® RFF (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU.
|
|---|---|---|
|
Adverse Events of Special Interest: Ovarian Hyperstimulation Syndrome (OHSS) - Cycle 1
Total Number of Subjects with OHSS
|
13 Participants
|
12 Participants
|
|
Adverse Events of Special Interest: Ovarian Hyperstimulation Syndrome (OHSS) - Cycle 1
Number of Subjects with Mild OHSS
|
6 Participants
|
4 Participants
|
|
Adverse Events of Special Interest: Ovarian Hyperstimulation Syndrome (OHSS) - Cycle 1
Number of Subjects with Moderate OHSS
|
5 Participants
|
6 Participants
|
|
Adverse Events of Special Interest: Ovarian Hyperstimulation Syndrome (OHSS) - Cycle 1
Number of Subjects with Severe OHSS
|
2 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Measured either 3 days after ooctye pick up (Visit 9) or 18 +/- 1 days after oocyte pick up (Visit 10).Population: Safety population, defined as all randomized subjects who received at least one dose of study treatment, based on their randomization.
Summary of the number of subjects with mild, moderate and severe OHSS. The total number of subjects with OHSS is also included.
Outcome measures
| Measure |
AFOLIA
n=109 Participants
One subcutaneous injection of 225IU AFOLIA (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU.
|
Gonal-f® RFF
n=120 Participants
One subcutaneous injection of 225IU Gonal-f® RFF (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU.
|
|---|---|---|
|
Adverse Events of Special Interest: Ovarian Hyperstimulation Syndrome (OHSS) - Cycle 2
Total Number of Subjects with OHSS
|
1 Participants
|
3 Participants
|
|
Adverse Events of Special Interest: Ovarian Hyperstimulation Syndrome (OHSS) - Cycle 2
Number of Subjects with Mild OHSS
|
1 Participants
|
1 Participants
|
|
Adverse Events of Special Interest: Ovarian Hyperstimulation Syndrome (OHSS) - Cycle 2
Number of Subjects with Moderate OHSS
|
0 Participants
|
2 Participants
|
|
Adverse Events of Special Interest: Ovarian Hyperstimulation Syndrome (OHSS) - Cycle 2
Number of Subjects with Severe OHSS
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Measured either 3 days after ooctye pick up (Visit 9) or 18 +/- 1 days after oocyte pick up (Visit 10).Population: Safety population, defined as all randomized subjects who received at least one dose of study treatment, based on their randomization.
Summary of the number of subjects with mild, moderate and severe OHSS. The total number of subjects with OHSS is also included.
Outcome measures
| Measure |
AFOLIA
n=28 Participants
One subcutaneous injection of 225IU AFOLIA (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU.
|
Gonal-f® RFF
n=24 Participants
One subcutaneous injection of 225IU Gonal-f® RFF (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU.
|
|---|---|---|
|
Adverse Events of Special Interest: Ovarian Hyperstimulation Syndrome (OHSS) - Cycle 3
Total Number of Subjects with OHSS
|
0 Participants
|
0 Participants
|
|
Adverse Events of Special Interest: Ovarian Hyperstimulation Syndrome (OHSS) - Cycle 3
Number of Subjects with Mild OHSS
|
0 Participants
|
0 Participants
|
|
Adverse Events of Special Interest: Ovarian Hyperstimulation Syndrome (OHSS) - Cycle 3
Number of Subjects with Moderate OHSS
|
0 Participants
|
0 Participants
|
|
Adverse Events of Special Interest: Ovarian Hyperstimulation Syndrome (OHSS) - Cycle 3
Number of Subjects with Severe OHSS
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Immunogenicity samples were taken at baseline, Visit 5 (8 days after start of treatment), Visit 9 (5 days after the end of FSH treatment), Visit 10 (18 +/- 1 days after oocyte retrieval), and Visit 11 (42 +/- 1 days after embryo transfer).Population: Safety population, defined as all randomized subjects who received at least one dose of study treatment, based on their randomization. Percentages are based on the number of subjects in the safety population with data at the respective visit.
Measurement of the number of subjects with detectable specific serum binding to FSH by surface Plasmon resonance during Cycle 1.
Outcome measures
| Measure |
AFOLIA
n=549 Participants
One subcutaneous injection of 225IU AFOLIA (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU.
|
Gonal-f® RFF
n=551 Participants
One subcutaneous injection of 225IU Gonal-f® RFF (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU.
|
|---|---|---|
|
Number of Subjects With Detectable Specific Serum Binding to FSH by Surface Plasmon Resonance - Cycle 1
Baseline
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Detectable Specific Serum Binding to FSH by Surface Plasmon Resonance - Cycle 1
Visit 5
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Detectable Specific Serum Binding to FSH by Surface Plasmon Resonance - Cycle 1
Visit 9
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Detectable Specific Serum Binding to FSH by Surface Plasmon Resonance - Cycle 1
Visit 10
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Detectable Specific Serum Binding to FSH by Surface Plasmon Resonance - Cycle 1
Visit 11
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Immunogenicity samples were taken at baseline, Visit 5 (8 days after start of treatment), Visit 9 (5 days after the end of FSH treatment), Visit 10 (18 +/- 1 days after oocyte retrieval), and Visit 11 (42 +/- 1 days after embryo transfer).Population: Safety population, defined as all randomized subjects who received at least one dose of study treatment, based on their randomization. Percentages are based on the number of subjects in the safety population with data at the respective visit.
Measurement of the number of subjects with detectable specific serum binding to FSH by surface Plasmon resonance during Cycle 2.
Outcome measures
| Measure |
AFOLIA
n=109 Participants
One subcutaneous injection of 225IU AFOLIA (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU.
|
Gonal-f® RFF
n=120 Participants
One subcutaneous injection of 225IU Gonal-f® RFF (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU.
|
|---|---|---|
|
Number of Subjects With Detectable Specific Serum Binding to FSH by Surface Plasmon Resonance - Cycle 2
Baseline
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Detectable Specific Serum Binding to FSH by Surface Plasmon Resonance - Cycle 2
Visit 5
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Detectable Specific Serum Binding to FSH by Surface Plasmon Resonance - Cycle 2
Visit 9
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Detectable Specific Serum Binding to FSH by Surface Plasmon Resonance - Cycle 2
Visit 10
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Detectable Specific Serum Binding to FSH by Surface Plasmon Resonance - Cycle 2
Visit 11
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Immunogenicity samples were taken at baseline, Visit 5 (8 days after start of treatment), Visit 9 (5 days after the end of FSH treatment), Visit 10 (18 +/- 1 days after oocyte retrieval), and Visit 11 (42 +/- 1 days after embryo transfer).Population: Safety population, defined as all randomized subjects who received at least one dose of study treatment, based on their randomization. Percentages are based on the number of subjects in the safety population with data at the respective visit.
Measurement of the number of subjects with detectable specific serum binding to FSH by surface Plasmon resonance during Cycle 3.
Outcome measures
| Measure |
AFOLIA
n=28 Participants
One subcutaneous injection of 225IU AFOLIA (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU.
|
Gonal-f® RFF
n=24 Participants
One subcutaneous injection of 225IU Gonal-f® RFF (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU.
|
|---|---|---|
|
Number of Subjects With Detectable Specific Serum Binding to FSH by Surface Plasmon Resonance - Cycle 3
Visit 10
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Detectable Specific Serum Binding to FSH by Surface Plasmon Resonance - Cycle 3
Baseline
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Detectable Specific Serum Binding to FSH by Surface Plasmon Resonance - Cycle 3
Visit 5
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Detectable Specific Serum Binding to FSH by Surface Plasmon Resonance - Cycle 3
Visit 9
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Detectable Specific Serum Binding to FSH by Surface Plasmon Resonance - Cycle 3
Visit 11
|
0 Participants
|
0 Participants
|
Adverse Events
AFOLIA - Cycle 1
Serious events: 32 serious events
Other events: 403 other events
Deaths: 0 deaths
Gonal-f® RFF - Cycle 1
Serious events: 31 serious events
Other events: 391 other events
Deaths: 1 deaths
AFOLIA - Cycle 2
Serious events: 2 serious events
Other events: 69 other events
Deaths: 0 deaths
Gonal-f® RFF - Cycle 2
Serious events: 6 serious events
Other events: 66 other events
Deaths: 0 deaths
AFOLIA - Cycle 3
Serious events: 3 serious events
Other events: 13 other events
Deaths: 0 deaths
Gonal-f® RFF - Cycle 3
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
AFOLIA - Cycle 1
n=549 participants at risk
Enrolled subjects in Cycle 1 were randomized to one subcutaneous injection of 225IU AFOLIA (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU.
|
Gonal-f® RFF - Cycle 1
n=551 participants at risk
Enrolled subjects in Cycle 1 were randomized to one subcutaneous injection of 225IU Gonal-f (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU.
|
AFOLIA - Cycle 2
n=109 participants at risk
Enrolled subjects in Cycle 2 were randomized to one subcutaneous injection of 225IU AFOLIA (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU.
|
Gonal-f® RFF - Cycle 2
n=120 participants at risk
Enrolled subjects in Cycle 2 were randomized to one subcutaneous injection of 225IU Gonal-f (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU.
|
AFOLIA - Cycle 3
n=28 participants at risk
Enrolled subjects in Cycle 3 were randomized to one subcutaneous injection of 225IU AFOLIA (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU.
|
Gonal-f® RFF - Cycle 3
n=24 participants at risk
Enrolled subjects in Cycle 3 were randomized to one subcutaneous injection of 225IU Gonal-f (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU.
|
|---|---|---|---|---|---|---|
|
Cardiac disorders
Foetal heart rate deceleration
|
0.00%
0/549
|
0.36%
2/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Congenital, familial and genetic disorders
Accessory auricle
|
0.18%
1/549
|
0.00%
0/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Congenital, familial and genetic disorders
Cardiac septal defect
|
0.00%
0/549
|
0.18%
1/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Congenital, familial and genetic disorders
Cleft palate
|
0.00%
0/549
|
0.18%
1/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Congenital, familial and genetic disorders
Congenital skin dimples
|
0.00%
0/549
|
0.18%
1/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Congenital, familial and genetic disorders
Cytogenetic abnormality
|
0.00%
0/549
|
0.18%
1/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Congenital, familial and genetic disorders
Foetal chromosome abnormality
|
0.18%
1/549
|
0.54%
3/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Congenital, familial and genetic disorders
Hypospadias
|
0.00%
0/549
|
0.18%
1/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Congenital, familial and genetic disorders
Mosaicism
|
0.18%
1/549
|
0.00%
0/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Congenital, familial and genetic disorders
Patent ductus arteriosus
|
0.00%
0/549
|
0.18%
1/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Congenital, familial and genetic disorders
Polydactyly
|
0.18%
1/549
|
0.00%
0/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Congenital, familial and genetic disorders
Trisomy 13
|
0.36%
2/549
|
0.00%
0/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Congenital, familial and genetic disorders
Trisomy 15
|
0.18%
1/549
|
0.36%
2/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Congenital, familial and genetic disorders
Trisomy 17
|
0.00%
0/549
|
0.00%
0/551
|
0.00%
0/109
|
0.83%
1/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Congenital, familial and genetic disorders
Trisomy 21
|
0.36%
2/549
|
0.00%
0/551
|
0.00%
0/109
|
1.7%
2/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Congenital, familial and genetic disorders
Trisomy 22
|
0.00%
0/549
|
0.18%
1/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Congenital, familial and genetic disorders
Trisomy 9
|
0.00%
0/549
|
0.18%
1/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Congenital, familial and genetic disorders
Turner's syndrome
|
0.18%
1/549
|
0.00%
0/551
|
0.00%
0/109
|
0.00%
0/120
|
3.6%
1/28
|
0.00%
0/24
|
|
Gastrointestinal disorders
Gastritis
|
0.18%
1/549
|
0.00%
0/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Gastrointestinal disorders
Peritoneal haemorrhage
|
0.00%
0/549
|
0.00%
0/551
|
0.00%
0/109
|
0.83%
1/120
|
0.00%
0/28
|
0.00%
0/24
|
|
General disorders
Death neonatal
|
0.18%
1/549
|
0.18%
1/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
General disorders
Pyrexia
|
0.00%
0/549
|
0.18%
1/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Hepatobiliary disorders
Acute fatty liver of pregnancy
|
0.00%
0/549
|
0.00%
0/551
|
0.92%
1/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Hepatobiliary disorders
Cholestasis
|
0.00%
0/549
|
0.18%
1/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Injury, poisoning and procedural complications
Fall
|
0.18%
1/549
|
0.00%
0/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Injury, poisoning and procedural complications
Post procedural haematuria
|
0.00%
0/549
|
0.18%
1/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.18%
1/549
|
0.00%
0/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/549
|
0.18%
1/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.18%
1/549
|
0.00%
0/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.36%
2/549
|
0.91%
5/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Pregnancy, puerperium and perinatal conditions
Cervical incompetence
|
0.18%
1/549
|
0.00%
0/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Pregnancy, puerperium and perinatal conditions
Ectopic pregnancy
|
0.36%
2/549
|
0.18%
1/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Pregnancy, puerperium and perinatal conditions
Foetal death
|
0.00%
0/549
|
0.18%
1/551
|
0.92%
1/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Pregnancy, puerperium and perinatal conditions
Foetal growth restriction
|
0.18%
1/549
|
0.00%
0/551
|
0.00%
0/109
|
0.83%
1/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Pregnancy, puerperium and perinatal conditions
Gestational hypertension
|
0.18%
1/549
|
0.00%
0/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Pregnancy, puerperium and perinatal conditions
Heterotopic pregnancy
|
0.18%
1/549
|
0.00%
0/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Pregnancy, puerperium and perinatal conditions
Hyperemesis gravidarum
|
0.00%
0/549
|
0.18%
1/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Pregnancy, puerperium and perinatal conditions
Postpartum haemorrhage
|
0.00%
0/549
|
0.18%
1/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Pregnancy, puerperium and perinatal conditions
Pre-eclampsia
|
0.18%
1/549
|
0.36%
2/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Pregnancy, puerperium and perinatal conditions
Premature baby
|
0.18%
1/549
|
0.18%
1/551
|
0.00%
0/109
|
0.00%
0/120
|
3.6%
1/28
|
0.00%
0/24
|
|
Pregnancy, puerperium and perinatal conditions
Premature labour
|
0.55%
3/549
|
0.36%
2/551
|
0.92%
1/109
|
0.83%
1/120
|
3.6%
1/28
|
0.00%
0/24
|
|
Pregnancy, puerperium and perinatal conditions
Premature rupture of membranes
|
0.73%
4/549
|
0.36%
2/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Pregnancy, puerperium and perinatal conditions
Prolonged labour
|
0.18%
1/549
|
0.00%
0/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Pregnancy, puerperium and perinatal conditions
Transverse presentation
|
0.00%
0/549
|
0.00%
0/551
|
0.00%
0/109
|
0.00%
0/120
|
3.6%
1/28
|
0.00%
0/24
|
|
Pregnancy, puerperium and perinatal conditions
Umbilical cord abnormality
|
0.00%
0/549
|
0.18%
1/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Pregnancy, puerperium and perinatal conditions
Vanishing twin syndrome
|
0.00%
0/549
|
0.00%
0/551
|
0.00%
0/109
|
0.83%
1/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Reproductive system and breast disorders
Ovarian hyperstimulation syndrome
|
0.00%
0/549
|
0.36%
2/551
|
0.00%
0/109
|
0.83%
1/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Reproductive system and breast disorders
Uterine haemorrhage
|
0.18%
1/549
|
0.00%
0/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Surgical and medical procedures
Abortion induced
|
0.18%
1/549
|
0.00%
0/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Vascular disorders
Hypertension
|
0.18%
1/549
|
0.00%
0/551
|
0.00%
0/109
|
0.83%
1/120
|
0.00%
0/28
|
0.00%
0/24
|
Other adverse events
| Measure |
AFOLIA - Cycle 1
n=549 participants at risk
Enrolled subjects in Cycle 1 were randomized to one subcutaneous injection of 225IU AFOLIA (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU.
|
Gonal-f® RFF - Cycle 1
n=551 participants at risk
Enrolled subjects in Cycle 1 were randomized to one subcutaneous injection of 225IU Gonal-f (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU.
|
AFOLIA - Cycle 2
n=109 participants at risk
Enrolled subjects in Cycle 2 were randomized to one subcutaneous injection of 225IU AFOLIA (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU.
|
Gonal-f® RFF - Cycle 2
n=120 participants at risk
Enrolled subjects in Cycle 2 were randomized to one subcutaneous injection of 225IU Gonal-f (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU.
|
AFOLIA - Cycle 3
n=28 participants at risk
Enrolled subjects in Cycle 3 were randomized to one subcutaneous injection of 225IU AFOLIA (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU.
|
Gonal-f® RFF - Cycle 3
n=24 participants at risk
Enrolled subjects in Cycle 3 were randomized to one subcutaneous injection of 225IU Gonal-f (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU.
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/549
|
0.36%
2/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Cardiac disorders
Palpitations
|
0.18%
1/549
|
0.00%
0/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Ear and labyrinth disorders
Ear discomfort
|
0.00%
0/549
|
0.18%
1/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/549
|
0.18%
1/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Ear and labyrinth disorders
Vertigo
|
0.18%
1/549
|
0.18%
1/551
|
0.92%
1/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Endocrine disorders
Hypothyroidism
|
0.36%
2/549
|
0.18%
1/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Eye disorders
Asthenopia
|
0.00%
0/549
|
0.36%
2/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Eye disorders
Conjunctivitis
|
0.18%
1/549
|
0.00%
0/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Eye disorders
Dry eye
|
0.18%
1/549
|
0.00%
0/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Eye disorders
Eye irritation
|
0.00%
0/549
|
0.18%
1/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Eye disorders
Vision blurred
|
0.18%
1/549
|
0.00%
0/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.91%
5/549
|
1.8%
10/551
|
1.8%
2/109
|
0.83%
1/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Gastrointestinal disorders
Abdominal distension
|
8.9%
49/549
|
7.6%
42/551
|
6.4%
7/109
|
3.3%
4/120
|
0.00%
0/28
|
4.2%
1/24
|
|
Gastrointestinal disorders
Abdominal pain
|
8.4%
46/549
|
9.8%
54/551
|
6.4%
7/109
|
5.0%
6/120
|
0.00%
0/28
|
8.3%
2/24
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.73%
4/549
|
0.18%
1/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.55%
3/549
|
0.73%
4/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Gastrointestinal disorders
Abdominal tenderness
|
1.3%
7/549
|
0.91%
5/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Gastrointestinal disorders
Ascites
|
0.73%
4/549
|
0.54%
3/551
|
0.92%
1/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Gastrointestinal disorders
Constipation
|
2.9%
16/549
|
2.7%
15/551
|
3.7%
4/109
|
2.5%
3/120
|
3.6%
1/28
|
0.00%
0/24
|
|
Gastrointestinal disorders
Dental caries
|
0.18%
1/549
|
0.00%
0/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Gastrointestinal disorders
Diarrhoea
|
2.4%
13/549
|
1.8%
10/551
|
3.7%
4/109
|
0.83%
1/120
|
0.00%
0/28
|
4.2%
1/24
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/549
|
0.36%
2/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Gastrointestinal disorders
Dyspepsia
|
1.5%
8/549
|
1.6%
9/551
|
0.92%
1/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Gastrointestinal disorders
Flatulence
|
0.55%
3/549
|
2.0%
11/551
|
0.00%
0/109
|
0.00%
0/120
|
3.6%
1/28
|
0.00%
0/24
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.00%
0/549
|
0.18%
1/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Gastrointestinal disorders
Gingival pain
|
0.18%
1/549
|
0.00%
0/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Gastrointestinal disorders
Glossodynia
|
0.18%
1/549
|
0.00%
0/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.18%
1/549
|
0.00%
0/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Gastrointestinal disorders
Hypoaesthesia oral
|
0.00%
0/549
|
0.18%
1/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Gastrointestinal disorders
Lip pain
|
0.18%
1/549
|
0.00%
0/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Gastrointestinal disorders
Localised intraabdominal fluid collection
|
0.18%
1/549
|
0.00%
0/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Gastrointestinal disorders
Nausea
|
9.7%
53/549
|
10.0%
55/551
|
7.3%
8/109
|
9.2%
11/120
|
0.00%
0/28
|
8.3%
2/24
|
|
Gastrointestinal disorders
Vomiting
|
2.0%
11/549
|
2.5%
14/551
|
0.92%
1/109
|
0.83%
1/120
|
0.00%
0/28
|
0.00%
0/24
|
|
General disorders
Adverse drug reaction
|
0.18%
1/549
|
0.00%
0/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
General disorders
Asthenia
|
0.00%
0/549
|
0.00%
0/551
|
0.00%
0/109
|
0.83%
1/120
|
0.00%
0/28
|
0.00%
0/24
|
|
General disorders
Chest discomfort
|
0.00%
0/549
|
0.18%
1/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
General disorders
Chills
|
0.18%
1/549
|
0.54%
3/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
General disorders
Crying
|
0.18%
1/549
|
0.00%
0/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
General disorders
Discomfort
|
0.18%
1/549
|
0.00%
0/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
General disorders
Fatigue
|
2.4%
13/549
|
2.5%
14/551
|
1.8%
2/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
General disorders
Feeling hot
|
0.00%
0/549
|
0.18%
1/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
General disorders
Inflammation
|
0.00%
0/549
|
0.00%
0/551
|
0.92%
1/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
General disorders
Injection site bruising
|
1.1%
6/549
|
1.5%
8/551
|
0.92%
1/109
|
0.83%
1/120
|
0.00%
0/28
|
0.00%
0/24
|
|
General disorders
Injection site erythema
|
14.9%
82/549
|
13.8%
76/551
|
10.1%
11/109
|
4.2%
5/120
|
7.1%
2/28
|
0.00%
0/24
|
|
General disorders
Injection site haematoma
|
0.55%
3/549
|
0.36%
2/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
General disorders
Injection site haemorrhage
|
0.00%
0/549
|
0.36%
2/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
General disorders
Injection site inflammation
|
0.00%
0/549
|
0.18%
1/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
General disorders
Injection site pain
|
0.18%
1/549
|
0.36%
2/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
General disorders
Injection site pruritus
|
0.00%
0/549
|
0.18%
1/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
General disorders
Injection site reaction
|
1.3%
7/549
|
1.3%
7/551
|
0.92%
1/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
General disorders
Injection site scab
|
0.36%
2/549
|
0.00%
0/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
General disorders
Injection site swelling
|
1.5%
8/549
|
0.73%
4/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
General disorders
Injection site vesicles
|
0.55%
3/549
|
0.73%
4/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
General disorders
Irritability
|
0.36%
2/549
|
0.00%
0/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
General disorders
Local swelling
|
0.36%
2/549
|
0.00%
0/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
General disorders
Malaise
|
0.36%
2/549
|
0.36%
2/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
General disorders
Non-cardiac chest pain
|
0.18%
1/549
|
0.00%
0/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
General disorders
Pain
|
0.00%
0/549
|
0.73%
4/551
|
0.00%
0/109
|
0.83%
1/120
|
0.00%
0/28
|
0.00%
0/24
|
|
General disorders
Pyrexia
|
0.36%
2/549
|
0.36%
2/551
|
0.92%
1/109
|
0.83%
1/120
|
0.00%
0/28
|
4.2%
1/24
|
|
General disorders
Vessel puncture site pain
|
0.00%
0/549
|
0.36%
2/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Immune system disorders
Drug hypersensitivity
|
0.18%
1/549
|
0.18%
1/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Immune system disorders
Seasonal allergy
|
0.55%
3/549
|
0.36%
2/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Infections and infestations
Body tinea
|
0.00%
0/549
|
0.18%
1/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Infections and infestations
Ear infection
|
0.00%
0/549
|
0.18%
1/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Infections and infestations
Folliculitis
|
0.00%
0/549
|
0.00%
0/551
|
0.00%
0/109
|
0.00%
0/120
|
3.6%
1/28
|
0.00%
0/24
|
|
Infections and infestations
Fungal infection
|
0.18%
1/549
|
0.36%
2/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/549
|
0.18%
1/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Infections and infestations
Genital herpes
|
0.00%
0/549
|
0.18%
1/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Infections and infestations
Herpes simplex
|
0.00%
0/549
|
0.18%
1/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Infections and infestations
Infected bites
|
0.00%
0/549
|
0.00%
0/551
|
0.00%
0/109
|
0.83%
1/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Infections and infestations
Influenza
|
0.00%
0/549
|
0.18%
1/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Infections and infestations
Nasopharyngitis
|
1.6%
9/549
|
1.1%
6/551
|
0.92%
1/109
|
0.83%
1/120
|
3.6%
1/28
|
0.00%
0/24
|
|
Infections and infestations
Oral herpes
|
0.00%
0/549
|
0.36%
2/551
|
0.92%
1/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/549
|
0.18%
1/551
|
0.92%
1/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Infections and infestations
Salpingitis
|
0.18%
1/549
|
0.00%
0/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Infections and infestations
Sinusitis
|
0.36%
2/549
|
0.73%
4/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Infections and infestations
Upper respiratory tract infection
|
0.55%
3/549
|
0.54%
3/551
|
0.92%
1/109
|
0.83%
1/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Infections and infestations
Urinary tract infection
|
0.73%
4/549
|
0.54%
3/551
|
0.92%
1/109
|
0.83%
1/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Infections and infestations
Vaginitis bacterial
|
0.00%
0/549
|
0.00%
0/551
|
0.92%
1/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
0.36%
2/549
|
0.00%
0/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.18%
1/549
|
0.00%
0/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/549
|
0.18%
1/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.36%
2/549
|
0.00%
0/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/549
|
0.18%
1/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/549
|
0.18%
1/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.00%
0/549
|
0.18%
1/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Injury, poisoning and procedural complications
Post procedural discomfort
|
7.1%
39/549
|
6.5%
36/551
|
7.3%
8/109
|
10.0%
12/120
|
10.7%
3/28
|
12.5%
3/24
|
|
Injury, poisoning and procedural complications
Post procedural haematuria
|
0.18%
1/549
|
0.00%
0/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.73%
4/549
|
0.54%
3/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Injury, poisoning and procedural complications
Procedural hypertension
|
0.36%
2/549
|
0.36%
2/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Injury, poisoning and procedural complications
Procedural nausea
|
2.7%
15/549
|
2.7%
15/551
|
1.8%
2/109
|
1.7%
2/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Injury, poisoning and procedural complications
Procedural pain
|
19.1%
105/549
|
16.2%
89/551
|
11.9%
13/109
|
9.2%
11/120
|
10.7%
3/28
|
8.3%
2/24
|
|
Injury, poisoning and procedural complications
Procedural vomiting
|
0.36%
2/549
|
0.54%
3/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Investigations
Blood oestrogen increased
|
0.18%
1/549
|
0.00%
0/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Investigations
Blood pressure increased
|
0.36%
2/549
|
0.18%
1/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Investigations
Blood urine present
|
0.18%
1/549
|
0.00%
0/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Investigations
Body temperature increased
|
0.18%
1/549
|
0.00%
0/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/549
|
0.18%
1/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Investigations
Heart rate increased
|
0.00%
0/549
|
0.00%
0/551
|
0.00%
0/109
|
0.83%
1/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/549
|
0.36%
2/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Investigations
Infertility tests
|
0.18%
1/549
|
0.00%
0/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Investigations
Weight decreased
|
0.00%
0/549
|
0.00%
0/551
|
0.00%
0/109
|
0.83%
1/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Investigations
Weight increased
|
0.00%
0/549
|
0.36%
2/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.18%
1/549
|
0.36%
2/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.18%
1/549
|
0.00%
0/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.36%
2/549
|
0.36%
2/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.6%
9/549
|
3.8%
21/551
|
0.92%
1/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/549
|
0.18%
1/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.36%
2/549
|
0.36%
2/551
|
0.92%
1/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.18%
1/549
|
0.00%
0/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
0.18%
1/549
|
0.00%
0/551
|
0.92%
1/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
1.6%
9/549
|
2.9%
16/551
|
0.00%
0/109
|
0.83%
1/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Musculoskeletal and connective tissue disorders
Muscle tightness
|
0.18%
1/549
|
0.00%
0/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
0.36%
2/549
|
0.18%
1/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.18%
1/549
|
0.00%
0/551
|
0.92%
1/109
|
0.83%
1/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.73%
4/549
|
0.73%
4/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.36%
2/549
|
0.54%
3/551
|
0.92%
1/109
|
0.83%
1/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.36%
2/549
|
0.18%
1/551
|
0.00%
0/109
|
0.83%
1/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leiomyoma
|
0.18%
1/549
|
0.00%
0/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.36%
2/549
|
0.18%
1/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Nervous system disorders
Aphonia
|
0.00%
0/549
|
0.18%
1/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Nervous system disorders
Dizziness
|
1.8%
10/549
|
1.3%
7/551
|
1.8%
2/109
|
0.83%
1/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Nervous system disorders
Dysgeusia
|
0.36%
2/549
|
0.54%
3/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Nervous system disorders
Headache
|
26.4%
145/549
|
23.0%
127/551
|
12.8%
14/109
|
13.3%
16/120
|
7.1%
2/28
|
20.8%
5/24
|
|
Nervous system disorders
Hyperaesthesia
|
0.18%
1/549
|
0.00%
0/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Nervous system disorders
Lethargy
|
0.18%
1/549
|
0.00%
0/551
|
0.00%
0/109
|
0.83%
1/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Nervous system disorders
Migraine
|
0.00%
0/549
|
1.3%
7/551
|
0.92%
1/109
|
0.83%
1/120
|
3.6%
1/28
|
0.00%
0/24
|
|
Nervous system disorders
Migraine with aura
|
0.18%
1/549
|
0.00%
0/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Nervous system disorders
Nerve compression
|
0.00%
0/549
|
0.18%
1/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Nervous system disorders
Paraesthesia
|
0.55%
3/549
|
0.00%
0/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Nervous system disorders
Poor quality sleep
|
0.00%
0/549
|
0.18%
1/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Nervous system disorders
Presyncope
|
0.18%
1/549
|
0.00%
0/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Nervous system disorders
Retinal migraine
|
0.18%
1/549
|
0.00%
0/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Nervous system disorders
Sciatica
|
0.00%
0/549
|
0.18%
1/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Nervous system disorders
Sinus headache
|
0.73%
4/549
|
0.36%
2/551
|
0.92%
1/109
|
0.83%
1/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Nervous system disorders
Somnolence
|
0.18%
1/549
|
0.00%
0/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Nervous system disorders
Syncope
|
0.18%
1/549
|
0.18%
1/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Nervous system disorders
Tension headache
|
0.00%
0/549
|
0.18%
1/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Pregnancy, puerperium and perinatal conditions
Abortion early
|
7.8%
43/549
|
10.9%
60/551
|
16.5%
18/109
|
13.3%
16/120
|
3.6%
1/28
|
8.3%
2/24
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
1.3%
7/549
|
1.6%
9/551
|
0.00%
0/109
|
0.83%
1/120
|
3.6%
1/28
|
0.00%
0/24
|
|
Pregnancy, puerperium and perinatal conditions
Cervical incompetence
|
0.18%
1/549
|
0.00%
0/551
|
0.00%
0/109
|
0.00%
0/120
|
3.6%
1/28
|
0.00%
0/24
|
|
Pregnancy, puerperium and perinatal conditions
Ectopic pregnancy
|
0.55%
3/549
|
0.73%
4/551
|
0.00%
0/109
|
0.83%
1/120
|
3.6%
1/28
|
0.00%
0/24
|
|
Pregnancy, puerperium and perinatal conditions
Gestational diabetes
|
0.18%
1/549
|
0.00%
0/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Pregnancy, puerperium and perinatal conditions
Haemorrhage in pregnancy
|
0.36%
2/549
|
0.73%
4/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Pregnancy, puerperium and perinatal conditions
Hyperemesis gravidarum
|
0.00%
0/549
|
0.18%
1/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Pregnancy, puerperium and perinatal conditions
Placenta praevia
|
0.18%
1/549
|
0.00%
0/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Pregnancy, puerperium and perinatal conditions
Premature rupture of membranes
|
0.00%
0/549
|
0.00%
0/551
|
0.00%
0/109
|
0.00%
0/120
|
3.6%
1/28
|
0.00%
0/24
|
|
Pregnancy, puerperium and perinatal conditions
Retained placenta or membranes
|
0.00%
0/549
|
0.00%
0/551
|
0.00%
0/109
|
0.00%
0/120
|
3.6%
1/28
|
0.00%
0/24
|
|
Pregnancy, puerperium and perinatal conditions
Subchorionic haematoma
|
0.36%
2/549
|
0.91%
5/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Pregnancy, puerperium and perinatal conditions
Subchorionic haemorrhage
|
0.55%
3/549
|
0.18%
1/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Pregnancy, puerperium and perinatal conditions
Vanishing twin syndrome
|
0.18%
1/549
|
1.1%
6/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Pregnancy, puerperium and perinatal conditions
Vomiting in pregnancy
|
0.36%
2/549
|
0.54%
3/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Psychiatric disorders
Anxiety
|
0.73%
4/549
|
0.18%
1/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Psychiatric disorders
Depressed mood
|
0.18%
1/549
|
0.00%
0/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Psychiatric disorders
Depression
|
0.00%
0/549
|
0.18%
1/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Psychiatric disorders
Emotional disorder
|
0.00%
0/549
|
0.18%
1/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Psychiatric disorders
Insomnia
|
1.3%
7/549
|
0.73%
4/551
|
0.92%
1/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Psychiatric disorders
Mood altered
|
0.36%
2/549
|
0.18%
1/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Psychiatric disorders
Mood swings
|
0.18%
1/549
|
0.00%
0/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Psychiatric disorders
Nightmare
|
0.00%
0/549
|
0.18%
1/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Psychiatric disorders
Restlessness
|
0.18%
1/549
|
0.00%
0/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Renal and urinary disorders
Dysuria
|
0.73%
4/549
|
0.54%
3/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Renal and urinary disorders
Haematuria
|
0.18%
1/549
|
0.00%
0/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Renal and urinary disorders
Micturition urgency
|
0.18%
1/549
|
0.00%
0/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Renal and urinary disorders
Pollakiuria
|
0.55%
3/549
|
0.36%
2/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Renal and urinary disorders
Urinary retention
|
0.18%
1/549
|
0.00%
0/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Reproductive system and breast disorders
Adnexa uteri pain
|
1.3%
7/549
|
0.54%
3/551
|
0.92%
1/109
|
0.00%
0/120
|
3.6%
1/28
|
0.00%
0/24
|
|
Reproductive system and breast disorders
Breast mass
|
0.00%
0/549
|
0.18%
1/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Reproductive system and breast disorders
Breast pain
|
0.36%
2/549
|
0.00%
0/551
|
0.92%
1/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Reproductive system and breast disorders
Breast tenderness
|
2.2%
12/549
|
1.5%
8/551
|
0.00%
0/109
|
1.7%
2/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Reproductive system and breast disorders
Cervical discharge
|
0.36%
2/549
|
0.00%
0/551
|
0.00%
0/109
|
0.83%
1/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Reproductive system and breast disorders
Cervical polyp
|
0.18%
1/549
|
0.00%
0/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Reproductive system and breast disorders
Coital bleeding
|
0.00%
0/549
|
0.18%
1/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.73%
4/549
|
0.54%
3/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Reproductive system and breast disorders
Fallopian tube cyst
|
0.18%
1/549
|
0.00%
0/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Reproductive system and breast disorders
Hypomenorrhoea
|
0.00%
0/549
|
0.18%
1/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.18%
1/549
|
0.36%
2/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Reproductive system and breast disorders
Nipple pain
|
0.18%
1/549
|
0.18%
1/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.18%
1/549
|
0.00%
0/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Reproductive system and breast disorders
Ovarian enlargement
|
0.55%
3/549
|
0.18%
1/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Reproductive system and breast disorders
Ovarian hyperstimulation syndrome
|
2.9%
16/549
|
2.2%
12/551
|
2.8%
3/109
|
1.7%
2/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Reproductive system and breast disorders
Pelvic discomfort
|
1.5%
8/549
|
1.8%
10/551
|
0.92%
1/109
|
0.00%
0/120
|
3.6%
1/28
|
0.00%
0/24
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.36%
2/549
|
1.1%
6/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Reproductive system and breast disorders
Uterine cervix stenosis
|
0.18%
1/549
|
0.00%
0/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Reproductive system and breast disorders
Uterine haemorrhage
|
0.36%
2/549
|
0.00%
0/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Reproductive system and breast disorders
Uterine pain
|
0.18%
1/549
|
0.18%
1/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Reproductive system and breast disorders
Uterine polyp
|
0.18%
1/549
|
0.18%
1/551
|
0.92%
1/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Reproductive system and breast disorders
Uterine spasm
|
1.5%
8/549
|
1.6%
9/551
|
1.8%
2/109
|
1.7%
2/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Reproductive system and breast disorders
Vaginal discharge
|
0.36%
2/549
|
0.73%
4/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
2.6%
14/549
|
3.4%
19/551
|
0.92%
1/109
|
1.7%
2/120
|
3.6%
1/28
|
0.00%
0/24
|
|
Reproductive system and breast disorders
Vaginal odour
|
0.18%
1/549
|
0.00%
0/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Reproductive system and breast disorders
Vulvovaginal discomfort
|
0.18%
1/549
|
0.73%
4/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Reproductive system and breast disorders
Vulvovaginal pruritus
|
0.18%
1/549
|
0.18%
1/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.36%
2/549
|
0.54%
3/551
|
0.00%
0/109
|
1.7%
2/120
|
0.00%
0/28
|
4.2%
1/24
|
|
Respiratory, thoracic and mediastinal disorders
Dry throat
|
0.18%
1/549
|
0.00%
0/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/549
|
0.18%
1/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.55%
3/549
|
0.18%
1/551
|
0.00%
0/109
|
0.83%
1/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.18%
1/549
|
0.00%
0/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
2.0%
11/549
|
1.8%
10/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
4.2%
1/24
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
1.8%
10/549
|
2.7%
15/551
|
1.8%
2/109
|
0.00%
0/120
|
0.00%
0/28
|
4.2%
1/24
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus discomfort
|
0.00%
0/549
|
0.00%
0/551
|
0.92%
1/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
0.00%
0/549
|
0.36%
2/551
|
0.92%
1/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.55%
3/549
|
1.1%
6/551
|
1.8%
2/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.36%
2/549
|
0.73%
4/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.55%
3/549
|
0.00%
0/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.00%
0/549
|
0.18%
1/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.18%
1/549
|
0.18%
1/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/549
|
0.36%
2/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Skin and subcutaneous tissue disorders
Blood blister
|
0.18%
1/549
|
0.00%
0/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.18%
1/549
|
0.18%
1/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Skin and subcutaneous tissue disorders
Ingrowing nail
|
0.18%
1/549
|
0.00%
0/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Skin and subcutaneous tissue disorders
Miliaria
|
0.18%
1/549
|
0.00%
0/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.36%
2/549
|
0.00%
0/551
|
0.92%
1/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/549
|
0.36%
2/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.55%
3/549
|
0.73%
4/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/549
|
0.18%
1/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.18%
1/549
|
0.00%
0/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.18%
1/549
|
0.00%
0/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Skin and subcutaneous tissue disorders
Skin discolouration
|
0.18%
1/549
|
0.00%
0/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
0.00%
0/549
|
0.18%
1/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Skin and subcutaneous tissue disorders
Skin reaction
|
0.18%
1/549
|
0.00%
0/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
0.00%
0/549
|
0.18%
1/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.18%
1/549
|
0.00%
0/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Surgical and medical procedures
Abortion induced
|
0.36%
2/549
|
0.00%
0/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Surgical and medical procedures
Sinus operation
|
0.18%
1/549
|
0.00%
0/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Surgical and medical procedures
Tooth extraction
|
0.00%
0/549
|
0.18%
1/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Surgical and medical procedures
Uterine dilation and curettage
|
0.00%
0/549
|
0.00%
0/551
|
0.00%
0/109
|
0.00%
0/120
|
3.6%
1/28
|
0.00%
0/24
|
|
Vascular disorders
Diastolic hypotension
|
0.00%
0/549
|
0.18%
1/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Vascular disorders
Flushing
|
0.18%
1/549
|
0.18%
1/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Vascular disorders
Hot flush
|
2.0%
11/549
|
1.5%
8/551
|
0.92%
1/109
|
2.5%
3/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Vascular disorders
Hypertension
|
0.18%
1/549
|
0.00%
0/551
|
0.00%
0/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
|
Vascular disorders
Hypotension
|
0.00%
0/549
|
0.00%
0/551
|
0.92%
1/109
|
0.00%
0/120
|
0.00%
0/28
|
0.00%
0/24
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Contract agreement. Results may not be published or referred to, in whole or in part, without the prior express written consent of the Sponsor.
- Publication restrictions are in place
Restriction type: OTHER