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Trial Outcomes & Findings for BEYOND Follow-up: Betaferon®/Betaseron® Efficacy Yielding Outcomes of a New Dose (NCT NCT00459667)

NCT ID: NCT00459667

Last Updated: 2015-04-23

Results Overview

The variable "Flu-like-syndrome" will consist of a combination of MedDRA terms (Preferred Terms and Lower Level Terms) indicative for this condition.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

1420 participants

Primary outcome timeframe

309 days

Results posted on

2015-04-23

Participant Flow

Eligible patients for this study included only those who completed the preceding BEYOND study. Patients were enrolled at the conclusion of the preceding study from 03 May 2007 until 14 March 2008. Patients who interrupted study medication in accordance with the investigator were eligible, provided it did not result in premature End of Study.

All enrolled patients who had been randomized during the predecessor study to IFNB 1b (Interferon 1b) continued on previously double-blinded medication in the BEYOND-FU study; all patients who had been previously randomized to Copaxone and all patients with premature end of study medication received open-label IFNB 1b 250 µg (IFNB 1b 250 µg\*).

Participant milestones

Participant milestones
Measure
IFNB-1b 500 mcg
Interferon beta 1b (\[IFNB 1b\] Betaseron) 500 mcg administered s.c. every other day (double blind)
IFNB-1b 250 mcg
Interferon beta 1b (\[IFNB 1b\] Betaseron) 250 mcg administered s.c. every other day (double blind)
IFNB-1b 250 mcg*
Interferon beta 1b (\[IFNB 1b\] Betaseron) 250 mcg administered s.c. every other day \*(Subjects who were administered Copaxone and subjects who had prematurely discontinued medication during BEYOND study.)
Overall Study
STARTED
592
647
181
Overall Study
Study Medication Dispensed
586
645
180
Overall Study
Started Treatment
586
644
180
Overall Study
COMPLETED
554
600
161
Overall Study
NOT COMPLETED
38
47
20

Reasons for withdrawal

Reasons for withdrawal
Measure
IFNB-1b 500 mcg
Interferon beta 1b (\[IFNB 1b\] Betaseron) 500 mcg administered s.c. every other day (double blind)
IFNB-1b 250 mcg
Interferon beta 1b (\[IFNB 1b\] Betaseron) 250 mcg administered s.c. every other day (double blind)
IFNB-1b 250 mcg*
Interferon beta 1b (\[IFNB 1b\] Betaseron) 250 mcg administered s.c. every other day \*(Subjects who were administered Copaxone and subjects who had prematurely discontinued medication during BEYOND study.)
Overall Study
Adverse Event
9
12
8
Overall Study
Lost to Follow-up
5
9
3
Overall Study
Pregnancy
1
1
1
Overall Study
Protocol Violation
1
0
0
Overall Study
Withdrawal by Subject
3
5
5
Overall Study
Other disease modifying treatment
1
2
1
Overall Study
Other reason (incl. 2 missing subjects)
12
15
1
Overall Study
No treatment administered
6
3
1

Baseline Characteristics

BEYOND Follow-up: Betaferon®/Betaseron® Efficacy Yielding Outcomes of a New Dose

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
IFNB-1b 500 mcg
n=586 Participants
Interferon beta 1b (\[IFNB 1b\] Betaseron) 500 mcg administered s.c. every other day (double blind)
IFNB-1b 250 mcg
n=645 Participants
Interferon beta 1b (\[IFNB 1b\] Betaseron) 250 mcg administered s.c. every other day (double blind)
IFNB-1b 250 mcg*
n=180 Participants
Interferon beta 1b (\[IFNB 1b\] Betaseron) 250 mcg administered s.c. every other day \*(Subjects who were administered Copaxone and subjects who had prematurely discontinued medication during BEYOND study.)
Total
n=1411 Participants
Total of all reporting groups
Age, Continuous
Mean±Standard Deviation
36.2 years
STANDARD_DEVIATION 9.36 • n=5 Participants
35.8 years
STANDARD_DEVIATION 9.17 • n=7 Participants
34.9 years
STANDARD_DEVIATION 9.5 • n=5 Participants
35.9 years
STANDARD_DEVIATION 9.29 • n=4 Participants
Age, Customized
<=18 years
6 participants
n=5 Participants
5 participants
n=7 Participants
2 participants
n=5 Participants
13 participants
n=4 Participants
Age, Customized
>18 and <55 years
580 participants
n=5 Participants
640 participants
n=7 Participants
178 participants
n=5 Participants
1398 participants
n=4 Participants
Age, Customized
>=55 years
0 participants
n=5 Participants
0 participants
n=7 Participants
0 participants
n=5 Participants
0 participants
n=4 Participants
Sex: Female, Male
Female
414 Participants
n=5 Participants
445 Participants
n=7 Participants
113 Participants
n=5 Participants
972 Participants
n=4 Participants
Sex: Female, Male
Male
172 Participants
n=5 Participants
200 Participants
n=7 Participants
67 Participants
n=5 Participants
439 Participants
n=4 Participants

PRIMARY outcome

Timeframe: 309 days

Population: The analysis set used for safety analysis (SAF) comprised 1411 patients. AEs were defined as events with an onset date after the first application of study drug. The incidence rate of Flu-Like-Syndrome with 95% confidence intervals were provided.

The variable "Flu-like-syndrome" will consist of a combination of MedDRA terms (Preferred Terms and Lower Level Terms) indicative for this condition.

Outcome measures

Outcome measures
Measure
IFNB-1b 500 mcg
n=586 Participants
Interferon beta 1b (\[IFNB 1b\] Betaseron) 500 mcg administered s.c. every other day (double blind)
IFNB-1b 250 mcg
n=645 Participants
Interferon beta 1b (\[IFNB 1b\] Betaseron) 250 mcg administered s.c. every other day (double blind)
IFNB-1b 250 mcg*
n=180 Participants
Interferon beta 1b (\[IFNB 1b\] Betaseron) 250 mcg administered s.c. every other day \*(Subjects who were administered Copaxone and subjects who had prematurely discontinued medication during BEYOND study.)
Flu-like-syndrome
17.4 Percentage of participants
15.8 Percentage of participants
31.1 Percentage of participants

PRIMARY outcome

Timeframe: 309 days

Population: The analysis set used for safety analysis (SAF) comprised 1411 patients. AEs were defined as events with an onset date after the first application of study drug. The incidence rate of Injection-site reactions with 95% confidence intervals were provided.

The variable "Injection-site reactions" will consist of a combination of MedDRA terms (Preferred Terms only) indicative for this condition.

Outcome measures

Outcome measures
Measure
IFNB-1b 500 mcg
n=586 Participants
Interferon beta 1b (\[IFNB 1b\] Betaseron) 500 mcg administered s.c. every other day (double blind)
IFNB-1b 250 mcg
n=645 Participants
Interferon beta 1b (\[IFNB 1b\] Betaseron) 250 mcg administered s.c. every other day (double blind)
IFNB-1b 250 mcg*
n=180 Participants
Interferon beta 1b (\[IFNB 1b\] Betaseron) 250 mcg administered s.c. every other day \*(Subjects who were administered Copaxone and subjects who had prematurely discontinued medication during BEYOND study.)
Injection-site Reactions
31.7 Percentage of participants
26.2 Percentage of participants
31.7 Percentage of participants

PRIMARY outcome

Timeframe: 309 days

Population: The analysis set used for safety analysis (SAF) comprised 1411 patients. AEs were defined as events with an onset date after the first application of study drug. The incidence rate of liver enzyme elevations were provided.

The variable "Liver enzyme elevations" will consist of a combination of MedDRA terms (Preferred Terms only) indicative for this condition.

Outcome measures

Outcome measures
Measure
IFNB-1b 500 mcg
n=586 Participants
Interferon beta 1b (\[IFNB 1b\] Betaseron) 500 mcg administered s.c. every other day (double blind)
IFNB-1b 250 mcg
n=645 Participants
Interferon beta 1b (\[IFNB 1b\] Betaseron) 250 mcg administered s.c. every other day (double blind)
IFNB-1b 250 mcg*
n=180 Participants
Interferon beta 1b (\[IFNB 1b\] Betaseron) 250 mcg administered s.c. every other day \*(Subjects who were administered Copaxone and subjects who had prematurely discontinued medication during BEYOND study.)
Liver Enzyme Elevations
GGT increased
2.7 Percentage of participants
1.2 Percentage of participants
3.9 Percentage of participants
Liver Enzyme Elevations
AST increased
2.0 Percentage of participants
1.4 Percentage of participants
3.9 Percentage of participants
Liver Enzyme Elevations
ALT increased
2.6 Percentage of participants
1.7 Percentage of participants
4.4 Percentage of participants

PRIMARY outcome

Timeframe: 309 days

Population: The analysis set used for safety analysis (SAF) comprised 1411 patients. AEs were defined as events with an onset date after the first application of study drug. The incidence rate of hematological abnormalities were provided.

The variable "Hematological abnormalities" will consist of a combination of MedDRA terms (Preferred Terms only) indicative for this condition.

Outcome measures

Outcome measures
Measure
IFNB-1b 500 mcg
n=586 Participants
Interferon beta 1b (\[IFNB 1b\] Betaseron) 500 mcg administered s.c. every other day (double blind)
IFNB-1b 250 mcg
n=645 Participants
Interferon beta 1b (\[IFNB 1b\] Betaseron) 250 mcg administered s.c. every other day (double blind)
IFNB-1b 250 mcg*
n=180 Participants
Interferon beta 1b (\[IFNB 1b\] Betaseron) 250 mcg administered s.c. every other day \*(Subjects who were administered Copaxone and subjects who had prematurely discontinued medication during BEYOND study.)
Hematological Abnormalities
White blood cells decreased
0.5 Percentage of participants
1.9 Percentage of participants
1.7 Percentage of participants
Hematological Abnormalities
Neutrophil count decreased
0.5 Percentage of participants
1.2 Percentage of participants
2.2 Percentage of participants
Hematological Abnormalities
Lymphocyte count decreased
1.5 Percentage of participants
0.6 Percentage of participants
0 Percentage of participants
Hematological Abnormalities
Platelet count decreased
0.7 Percentage of participants
0.2 Percentage of participants
0.6 Percentage of participants
Hematological Abnormalities
Hemoglobin decreased
1.2 Percentage of participants
1.1 Percentage of participants
0 Percentage of participants

SECONDARY outcome

Timeframe: 309 days

Population: For the NAb analyses data were provided for 572 patients at Baseline, 238 at Week 26 and 1261 at EOS. The patients missing to the total number of 1411 patients had no data at the respective visits (table shows number of patients with positive titer in the extension treatment cohorts; the analyses provide frequencies of positive titers).

Serum samples of about 8 mL for analysis of neutralizing antibodies (NAbs) to interferon (IFN) beta-1b were drawn at Baseline, Week 26 and the EOS visit.

Outcome measures

Outcome measures
Measure
IFNB-1b 500 mcg
n=527 Participants
Interferon beta 1b (\[IFNB 1b\] Betaseron) 500 mcg administered s.c. every other day (double blind)
IFNB-1b 250 mcg
n=571 Participants
Interferon beta 1b (\[IFNB 1b\] Betaseron) 250 mcg administered s.c. every other day (double blind)
IFNB-1b 250 mcg*
n=163 Participants
Interferon beta 1b (\[IFNB 1b\] Betaseron) 250 mcg administered s.c. every other day \*(Subjects who were administered Copaxone and subjects who had prematurely discontinued medication during BEYOND study.)
Percentage of Patients With Neutralizing Antibody Titer to IFNB-1b of Different Cut-off Values
NAbs titer, cut-off value 20 NU/ml
26.6 Percentage of participants
21.7 Percentage of participants
16.6 Percentage of participants
Percentage of Patients With Neutralizing Antibody Titer to IFNB-1b of Different Cut-off Values
NAbs titer, cut-off value 100 NU/ml
16.5 Percentage of participants
12.4 Percentage of participants
2.5 Percentage of participants
Percentage of Patients With Neutralizing Antibody Titer to IFNB-1b of Different Cut-off Values
NAbs titer, cut-off value 400 NU/ml
10.8 Percentage of participants
6.1 Percentage of participants
0 Percentage of participants

Adverse Events

IFNB-1b 500 mcg

Serious events: 11 serious events
Other events: 455 other events
Deaths: 0 deaths

IFNB-1b 250 mcg

Serious events: 16 serious events
Other events: 467 other events
Deaths: 0 deaths

IFNB-1b 250 mcg*

Serious events: 6 serious events
Other events: 136 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
IFNB-1b 500 mcg
n=586 participants at risk
Interferon beta 1b (\[IFNB 1b\] Betaseron) 500 mcg administered s.c. every other day (double blind)
IFNB-1b 250 mcg
n=645 participants at risk
Interferon beta 1b (\[IFNB 1b\] Betaseron) 250 mcg administered s.c. every other day (double blind)
IFNB-1b 250 mcg*
n=180 participants at risk
Interferon beta 1b (\[IFNB 1b\] Betaseron) 250 mcg administered s.c. every other day \*(Subjects who were administered Copaxone and subjects who had prematurely discontinued medication during BEYOND study.)
Nervous system disorders
Carotid artery stenosis
0.00%
0/586
0.16%
1/645
0.00%
0/180
Nervous system disorders
Multiple Sclerosis
0.17%
1/586
0.00%
0/645
0.00%
0/180
Nervous system disorders
Optic neuritis
0.17%
1/586
0.00%
0/645
0.00%
0/180
Nervous system disorders
Sciatica
0.17%
1/586
0.00%
0/645
0.00%
0/180
Nervous system disorders
Transient ischaemic attack
0.00%
0/586
0.16%
1/645
0.00%
0/180
Injury, poisoning and procedural complications
Contusion
0.17%
1/586
0.00%
0/645
0.00%
0/180
Injury, poisoning and procedural complications
Humerus fracture
0.17%
1/586
0.00%
0/645
0.00%
0/180
Injury, poisoning and procedural complications
Joint sprain
0.17%
1/586
0.00%
0/645
0.00%
0/180
Injury, poisoning and procedural complications
Ligament injury
0.00%
0/586
0.16%
1/645
0.00%
0/180
Injury, poisoning and procedural complications
Rib fracture
0.17%
1/586
0.00%
0/645
0.00%
0/180
Injury, poisoning and procedural complications
Tibia fracture
0.00%
0/586
0.16%
1/645
0.00%
0/180
Injury, poisoning and procedural complications
Wound
0.00%
0/586
0.16%
1/645
0.00%
0/180
Surgical and medical procedures
Bladder catheter replacement
0.00%
0/586
0.00%
0/645
0.56%
1/180
Surgical and medical procedures
Elective surgery
0.17%
1/586
0.00%
0/645
1.1%
2/180
Surgical and medical procedures
Rehabilitation therapy
0.17%
1/586
0.00%
0/645
0.00%
0/180
Cardiac disorders
Angina pectoris
0.00%
0/586
0.16%
1/645
0.00%
0/180
Cardiac disorders
Coronary artery disease
0.17%
1/586
0.00%
0/645
0.00%
0/180
Congenital, familial and genetic disorders
Dandy-Walker syndrome
0.17%
1/586
0.00%
0/645
0.00%
0/180
Hepatobiliary disorders
Bile duct stone
0.00%
0/586
0.00%
0/645
0.56%
1/180
Hepatobiliary disorders
Cholecystitis
0.17%
1/586
0.00%
0/645
0.00%
0/180
Hepatobiliary disorders
Cholecystitis acute
0.00%
0/586
0.00%
0/645
0.56%
1/180
Hepatobiliary disorders
Cholelithiasis
0.00%
0/586
0.00%
0/645
0.56%
1/180
Hepatobiliary disorders
Jaundice cholestatic
0.00%
0/586
0.00%
0/645
0.56%
1/180
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anal cancer
0.00%
0/586
0.16%
1/645
0.00%
0/180
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
0.17%
1/586
0.00%
0/645
0.00%
0/180
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cervix carcinoma
0.00%
0/586
0.16%
1/645
0.00%
0/180
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial cancer
0.00%
0/586
0.16%
1/645
0.00%
0/180
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
0.00%
0/586
0.16%
1/645
0.00%
0/180
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
0.00%
0/586
0.16%
1/645
0.00%
0/180
Respiratory, thoracic and mediastinal disorders
Dyspnoea
0.17%
1/586
0.00%
0/645
0.00%
0/180
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
0.17%
1/586
0.00%
0/645
0.00%
0/180
Gastrointestinal disorders
Abdominal pain upper
0.00%
0/586
0.00%
0/645
0.56%
1/180
General disorders
Chest pain
0.00%
0/586
0.00%
0/645
0.56%
1/180
General disorders
Papillitis
0.00%
0/586
0.00%
0/645
0.56%
1/180
Infections and infestations
Diverticulitis
0.00%
0/586
0.16%
1/645
0.00%
0/180
Infections and infestations
Injection site cellulitis
0.00%
0/586
0.16%
1/645
0.00%
0/180
Investigations
Arteriogram coronary
0.00%
0/586
0.16%
1/645
0.00%
0/180
Investigations
Platelet aggregation
0.00%
0/586
0.16%
1/645
0.00%
0/180
Musculoskeletal and connective tissue disorders
Costochondritis
0.00%
0/586
0.16%
1/645
0.00%
0/180
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
0.00%
0/586
0.16%
1/645
0.00%
0/180
Musculoskeletal and connective tissue disorders
Muscle spasm
0.00%
0/586
0.16%
1/645
0.00%
0/180
Pregnancy, puerperium and perinatal conditions
Intra-uterine death
0.00%
0/586
0.00%
0/645
0.56%
1/180
Psychiatric disorders
Depression
0.00%
0/586
0.16%
1/645
0.00%
0/180
Renal and urinary disorders
Hydronephrosis
0.00%
0/586
0.16%
1/645
0.00%
0/180
Renal and urinary disorders
Renal failure actue
0.00%
0/586
0.16%
1/645
0.00%
0/180
Renal and urinary disorders
Ureteric obstruction
0.00%
0/586
0.16%
1/645
0.00%
0/180
Reproductive system and breast disorders
Metrorrhagia
0.00%
0/586
0.16%
1/645
0.00%
0/180
Vascular disorders
Hypertensive crisis
0.00%
0/586
0.00%
0/645
0.56%
1/180

Other adverse events

Other adverse events
Measure
IFNB-1b 500 mcg
n=586 participants at risk
Interferon beta 1b (\[IFNB 1b\] Betaseron) 500 mcg administered s.c. every other day (double blind)
IFNB-1b 250 mcg
n=645 participants at risk
Interferon beta 1b (\[IFNB 1b\] Betaseron) 250 mcg administered s.c. every other day (double blind)
IFNB-1b 250 mcg*
n=180 participants at risk
Interferon beta 1b (\[IFNB 1b\] Betaseron) 250 mcg administered s.c. every other day \*(Subjects who were administered Copaxone and subjects who had prematurely discontinued medication during BEYOND study.)
General disorders
Astenia
1.7%
10/586
2.2%
14/645
0.00%
0/180
General disorders
Chills
0.68%
4/586
1.1%
7/645
2.2%
4/180
General disorders
Fatigue
15.2%
89/586
13.8%
89/645
12.8%
23/180
General disorders
Influenza like illness
12.3%
72/586
9.6%
62/645
20.6%
37/180
General disorders
Injection site bruising
3.1%
18/586
1.9%
12/645
1.7%
3/180
General disorders
Injection site erythema
11.9%
70/586
11.3%
73/645
9.4%
17/180
General disorders
Injection site induration
0.51%
3/586
0.31%
2/645
2.2%
4/180
General disorders
Injection site mass
0.68%
4/586
0.16%
1/645
2.2%
4/180
General disorders
Injection site nodule
0.00%
0/586
0.16%
1/645
2.8%
5/180
General disorders
Injection site pain
4.3%
25/586
2.6%
17/645
6.1%
11/180
General disorders
Injection site reaction
13.7%
80/586
10.9%
70/645
11.1%
20/180
General disorders
Pain
2.6%
15/586
0.93%
6/645
1.7%
3/180
General disorders
Pyrexia
1.0%
6/586
0.31%
2/645
5.6%
10/180
Nervous system disorders
Dizziness
2.7%
16/586
2.0%
13/645
1.7%
3/180
Nervous system disorders
Headache
12.3%
72/586
13.8%
89/645
14.4%
26/180
Nervous system disorders
Hypoaesthesia
3.2%
19/586
3.6%
23/645
3.9%
7/180
Nervous system disorders
Migraine
1.4%
8/586
2.3%
15/645
1.1%
2/180
Nervous system disorders
Multiple sclerosis relapse
7.7%
45/586
11.0%
71/645
7.2%
13/180
Nervous system disorders
Muscle spasticity
1.9%
11/586
1.7%
11/645
3.9%
7/180
Nervous system disorders
Paraesthesia
4.4%
26/586
6.7%
43/645
6.7%
12/180
Musculoskeletal and connective tissue disorders
Arthralgia
4.3%
25/586
5.1%
33/645
6.7%
12/180
Musculoskeletal and connective tissue disorders
Back pain
6.0%
35/586
4.7%
30/645
3.3%
6/180
Musculoskeletal and connective tissue disorders
Muscle spams
4.4%
26/586
3.6%
23/645
3.3%
6/180
Musculoskeletal and connective tissue disorders
Muscular weakness
2.7%
16/586
2.2%
14/645
1.7%
3/180
Musculoskeletal and connective tissue disorders
Myalgia
2.2%
13/586
2.9%
19/645
3.9%
7/180
Musculoskeletal and connective tissue disorders
Pain in extremitiy
4.8%
28/586
4.5%
29/645
7.8%
14/180
Infections and infestations
Nasopharyngitis
1.9%
11/586
3.3%
21/645
4.4%
8/180
Infections and infestations
Sinusitis
0.85%
5/586
1.2%
8/645
2.2%
4/180
Infections and infestations
Upper respiratory tract infection
1.0%
6/586
1.9%
12/645
5.6%
10/180
Infections and infestations
Urinary tract infection
1.5%
9/586
1.4%
9/645
4.4%
8/180
Investigations
Alanine aminotransferase increased
2.6%
15/586
1.7%
11/645
4.4%
8/180
Investigations
Aspartate aminotransferase increased
2.0%
12/586
1.4%
9/645
3.9%
7/180
Investigations
Gamma-glutamyltransferase increased
2.7%
16/586
1.2%
8/645
3.9%
7/180
Investigations
Neutrophil count decreased
0.51%
3/586
1.2%
8/645
2.2%
4/180
Psychiatric disorders
Anxiety
4.3%
25/586
4.2%
27/645
3.3%
6/180
Psychiatric disorders
Depression
9.6%
56/586
9.3%
60/645
12.8%
23/180
Gastrointestinal disorders
Constipation
1.9%
11/586
1.9%
12/645
3.9%
7/180
Renal and urinary disorders
Micturition urgency
2.2%
13/586
0.93%
6/645
1.1%
2/180
Blood and lymphatic system disorders
Leukopenia
2.6%
15/586
2.6%
17/645
2.8%
5/180
Blood and lymphatic system disorders
Neutropenia
2.4%
14/586
0.78%
5/645
1.7%
3/180
Vascular disorders
Hypertension
3.8%
22/586
4.0%
26/645
3.9%
7/180
Eye disorders
Vision blurred
1.5%
9/586
1.9%
12/645
2.2%
4/180
Ear and labyrinth disorders
Vertigo
1.9%
11/586
1.4%
9/645
2.2%
4/180
Gastrointestinal disorders
Nausea
1.2%
7/586
1.4%
9/645
3.3%
6/180
General disorders
Injection site atrophy
0.00%
0/586
0.16%
1/645
2.2%
4/180
General disorders
Oedema peripheral
0.34%
2/586
0.47%
3/645
2.2%
4/180
Infections and infestations
Pharyngitis
0.68%
4/586
0.31%
2/645
2.2%
4/180
Nervous system disorders
Burning sensation
0.34%
2/586
1.2%
8/645
2.8%
5/180
Renal and urinary disorders
Urinary incontinence
0.68%
4/586
1.1%
7/645
2.2%
4/180
Reproductive system and breast disorders
Menopausal symptoms
0.51%
3/586
0.16%
1/645
2.2%
4/180
Psychiatric disorders
Insomnia
3.9%
23/586
5.4%
35/645
3.9%
7/180

Additional Information

Therapeutic Area Head

BAYER

Results disclosure agreements

  • Principal investigator is a sponsor employee The sponsor is interested in the publication of the results of every study it performs. As some of the information concerning the study drug and the sponsor's development activities may be strictly confidential, any publication manuscript (including conference contributions, etc.) must first be reviewed by the sponsor before its submission or presentation. Publication of subgroup data and single center data shall not be performed until the complete study has been published.
  • Publication restrictions are in place

Restriction type: OTHER