Trial Outcomes & Findings for Tamoxifen Compared With Thalidomide in Treating Women With Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer (NCT NCT00041080)
NCT ID: NCT00041080
Last Updated: 2019-07-30
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
139 participants
Primary outcome timeframe
from enrollment onto the study until first disease progression or death due to any cause
Results posted on
2019-07-30
Participant Flow
Enrollment began Feb 3, 2003 and completed Jan 30, 2011. All patients were enrolled from GOG member institutions in the United States.
Eligible patients had histologically confirmed ovarian, fallopian tube or primary peritoneal cancer. They had rising CA-125 that exceeded twice the upper-limit of normal, but no radiographic or physical evidence of disease following first-line chemotherapy.
Participant milestones
| Measure |
Grp - 1
Thalidomide 200mg orally daily with weekly escalation of 100mg to a maximum dose of 400mg until progression or additional therapy prohibited further therapy.
|
Grp - 2
Tamoxifen 20mg orally twice daily for up to 12 28-day cycles until progression or adverse effect prohibited additional therapy.
|
|---|---|---|
|
Overall Study
STARTED
|
69
|
70
|
|
Overall Study
COMPLETED
|
39
|
60
|
|
Overall Study
NOT COMPLETED
|
30
|
10
|
Reasons for withdrawal
| Measure |
Grp - 1
Thalidomide 200mg orally daily with weekly escalation of 100mg to a maximum dose of 400mg until progression or additional therapy prohibited further therapy.
|
Grp - 2
Tamoxifen 20mg orally twice daily for up to 12 28-day cycles until progression or adverse effect prohibited additional therapy.
|
|---|---|---|
|
Overall Study
Adverse Event
|
21
|
1
|
|
Overall Study
Withdrawal by Subject
|
6
|
6
|
|
Overall Study
Concommitant Illness/Other
|
1
|
2
|
|
Overall Study
Did not start therapy
|
1
|
1
|
|
Overall Study
Ineligible
|
1
|
0
|
Baseline Characteristics
Tamoxifen Compared With Thalidomide in Treating Women With Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer
Baseline characteristics by cohort
| Measure |
Grp - 1
n=68 Participants
Thalidomide 200mg orally daily with weekly escalation of 100mg to a maximum dose of 400mg until progression or additional therapy prohibited further therapy.
|
Grp - 2
n=70 Participants
Tamoxifen 20mg orally for up to 12 28-day cycles until progression or adverse effect prohibited additional therapy.
|
Total
n=138 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64.3 years
STANDARD_DEVIATION 10.8 • n=93 Participants
|
61.6 years
STANDARD_DEVIATION 10.5 • n=4 Participants
|
62.9 years
STANDARD_DEVIATION 10.7 • n=27 Participants
|
|
Age, Customized
< 50 years
|
7 participants
n=93 Participants
|
12 participants
n=4 Participants
|
19 participants
n=27 Participants
|
|
Age, Customized
50-59 years
|
17 participants
n=93 Participants
|
14 participants
n=4 Participants
|
31 participants
n=27 Participants
|
|
Age, Customized
60-69 years
|
22 participants
n=93 Participants
|
28 participants
n=4 Participants
|
50 participants
n=27 Participants
|
|
Age, Customized
70-79 years
|
17 participants
n=93 Participants
|
15 participants
n=4 Participants
|
32 participants
n=27 Participants
|
|
Age, Customized
80-89 years
|
5 participants
n=93 Participants
|
1 participants
n=4 Participants
|
6 participants
n=27 Participants
|
|
Sex: Female, Male
Female
|
68 Participants
n=93 Participants
|
70 Participants
n=4 Participants
|
138 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Gynecologic Oncology Group (GOG) Performance Status
0 - asymptomatic
|
63 participants
n=93 Participants
|
67 participants
n=4 Participants
|
130 participants
n=27 Participants
|
|
Gynecologic Oncology Group (GOG) Performance Status
1 - symptomatic
|
5 participants
n=93 Participants
|
3 participants
n=4 Participants
|
8 participants
n=27 Participants
|
|
Primary Site of Disease
Ovary
|
58 participants
n=93 Participants
|
59 participants
n=4 Participants
|
117 participants
n=27 Participants
|
|
Primary Site of Disease
Peritoneum
|
10 participants
n=93 Participants
|
10 participants
n=4 Participants
|
20 participants
n=27 Participants
|
|
Primary Site of Disease
Fallopian Tube
|
0 participants
n=93 Participants
|
1 participants
n=4 Participants
|
1 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: from enrollment onto the study until first disease progression or death due to any causeOutcome measures
| Measure |
Grp - 1
n=68 Participants
Thalidomide 200mg orally daily with weekly escalation of 100mg to a maximum dose of 400mg until progression or additional therapy prohibited further therapy.
|
Grp - 2
n=70 Participants
Tamoxifen 20mg orally for up to 12 28-day cycles until progression or adverse effect prohibited additional therapy.
|
|---|---|---|
|
Median Progression-free Survival
|
3.2 months
Interval 2.7 to 3.9
|
4.5 months
Interval 2.7 to 5.5
|
Adverse Events
Grp - 1
Serious events: 3 serious events
Other events: 42 other events
Deaths: 0 deaths
Grp - 2
Serious events: 1 serious events
Other events: 24 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Grp - 1
n=67 participants at risk
Thalidomide 200mg orally daily with weekly escalation of 100mg to a maximum dose of 400mg until progression or additional therapy prohibited further therapy.
|
Grp - 2
n=69 participants at risk
Tamoxifen 20mg orally for up to 12 28-day cycles until progression or adverse effect prohibited additional therapy.
|
|---|---|---|
|
Blood and lymphatic system disorders
Neutropenia/Granulocytopenia
|
1.5%
1/67 • Within 30 days after stopping study treatment or any SAE that the study investigator felt was study treatment related.
Other Adverse Events(AEs) are at least possibly related to study treatment. Due to the methods in which adverse events were collected and/or stored for this study, it is not possible to report only the Other (not including Serious) AEs in the appropriate table. Therefore, the Other AEs table includes a combined set of serious and non-serious AEs.
|
0.00%
0/69 • Within 30 days after stopping study treatment or any SAE that the study investigator felt was study treatment related.
Other Adverse Events(AEs) are at least possibly related to study treatment. Due to the methods in which adverse events were collected and/or stored for this study, it is not possible to report only the Other (not including Serious) AEs in the appropriate table. Therefore, the Other AEs table includes a combined set of serious and non-serious AEs.
|
|
Cardiac disorders
Sinus tachycardia
|
1.5%
1/67 • Within 30 days after stopping study treatment or any SAE that the study investigator felt was study treatment related.
Other Adverse Events(AEs) are at least possibly related to study treatment. Due to the methods in which adverse events were collected and/or stored for this study, it is not possible to report only the Other (not including Serious) AEs in the appropriate table. Therefore, the Other AEs table includes a combined set of serious and non-serious AEs.
|
0.00%
0/69 • Within 30 days after stopping study treatment or any SAE that the study investigator felt was study treatment related.
Other Adverse Events(AEs) are at least possibly related to study treatment. Due to the methods in which adverse events were collected and/or stored for this study, it is not possible to report only the Other (not including Serious) AEs in the appropriate table. Therefore, the Other AEs table includes a combined set of serious and non-serious AEs.
|
|
Cardiac disorders
Thrombosis/embolism
|
1.5%
1/67 • Within 30 days after stopping study treatment or any SAE that the study investigator felt was study treatment related.
Other Adverse Events(AEs) are at least possibly related to study treatment. Due to the methods in which adverse events were collected and/or stored for this study, it is not possible to report only the Other (not including Serious) AEs in the appropriate table. Therefore, the Other AEs table includes a combined set of serious and non-serious AEs.
|
1.4%
1/69 • Within 30 days after stopping study treatment or any SAE that the study investigator felt was study treatment related.
Other Adverse Events(AEs) are at least possibly related to study treatment. Due to the methods in which adverse events were collected and/or stored for this study, it is not possible to report only the Other (not including Serious) AEs in the appropriate table. Therefore, the Other AEs table includes a combined set of serious and non-serious AEs.
|
|
Gastrointestinal disorders
Constipation
|
4.5%
3/67 • Within 30 days after stopping study treatment or any SAE that the study investigator felt was study treatment related.
Other Adverse Events(AEs) are at least possibly related to study treatment. Due to the methods in which adverse events were collected and/or stored for this study, it is not possible to report only the Other (not including Serious) AEs in the appropriate table. Therefore, the Other AEs table includes a combined set of serious and non-serious AEs.
|
0.00%
0/69 • Within 30 days after stopping study treatment or any SAE that the study investigator felt was study treatment related.
Other Adverse Events(AEs) are at least possibly related to study treatment. Due to the methods in which adverse events were collected and/or stored for this study, it is not possible to report only the Other (not including Serious) AEs in the appropriate table. Therefore, the Other AEs table includes a combined set of serious and non-serious AEs.
|
|
Gastrointestinal disorders
Diarrhea
|
1.5%
1/67 • Within 30 days after stopping study treatment or any SAE that the study investigator felt was study treatment related.
Other Adverse Events(AEs) are at least possibly related to study treatment. Due to the methods in which adverse events were collected and/or stored for this study, it is not possible to report only the Other (not including Serious) AEs in the appropriate table. Therefore, the Other AEs table includes a combined set of serious and non-serious AEs.
|
0.00%
0/69 • Within 30 days after stopping study treatment or any SAE that the study investigator felt was study treatment related.
Other Adverse Events(AEs) are at least possibly related to study treatment. Due to the methods in which adverse events were collected and/or stored for this study, it is not possible to report only the Other (not including Serious) AEs in the appropriate table. Therefore, the Other AEs table includes a combined set of serious and non-serious AEs.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/67 • Within 30 days after stopping study treatment or any SAE that the study investigator felt was study treatment related.
Other Adverse Events(AEs) are at least possibly related to study treatment. Due to the methods in which adverse events were collected and/or stored for this study, it is not possible to report only the Other (not including Serious) AEs in the appropriate table. Therefore, the Other AEs table includes a combined set of serious and non-serious AEs.
|
1.4%
1/69 • Within 30 days after stopping study treatment or any SAE that the study investigator felt was study treatment related.
Other Adverse Events(AEs) are at least possibly related to study treatment. Due to the methods in which adverse events were collected and/or stored for this study, it is not possible to report only the Other (not including Serious) AEs in the appropriate table. Therefore, the Other AEs table includes a combined set of serious and non-serious AEs.
|
|
Gastrointestinal disorders
Partial small bowel obstruction
|
1.5%
1/67 • Within 30 days after stopping study treatment or any SAE that the study investigator felt was study treatment related.
Other Adverse Events(AEs) are at least possibly related to study treatment. Due to the methods in which adverse events were collected and/or stored for this study, it is not possible to report only the Other (not including Serious) AEs in the appropriate table. Therefore, the Other AEs table includes a combined set of serious and non-serious AEs.
|
0.00%
0/69 • Within 30 days after stopping study treatment or any SAE that the study investigator felt was study treatment related.
Other Adverse Events(AEs) are at least possibly related to study treatment. Due to the methods in which adverse events were collected and/or stored for this study, it is not possible to report only the Other (not including Serious) AEs in the appropriate table. Therefore, the Other AEs table includes a combined set of serious and non-serious AEs.
|
|
Hepatobiliary disorders
SGPT
|
1.5%
1/67 • Within 30 days after stopping study treatment or any SAE that the study investigator felt was study treatment related.
Other Adverse Events(AEs) are at least possibly related to study treatment. Due to the methods in which adverse events were collected and/or stored for this study, it is not possible to report only the Other (not including Serious) AEs in the appropriate table. Therefore, the Other AEs table includes a combined set of serious and non-serious AEs.
|
0.00%
0/69 • Within 30 days after stopping study treatment or any SAE that the study investigator felt was study treatment related.
Other Adverse Events(AEs) are at least possibly related to study treatment. Due to the methods in which adverse events were collected and/or stored for this study, it is not possible to report only the Other (not including Serious) AEs in the appropriate table. Therefore, the Other AEs table includes a combined set of serious and non-serious AEs.
|
|
Infections and infestations
Febrile Neutropenia
|
1.5%
1/67 • Within 30 days after stopping study treatment or any SAE that the study investigator felt was study treatment related.
Other Adverse Events(AEs) are at least possibly related to study treatment. Due to the methods in which adverse events were collected and/or stored for this study, it is not possible to report only the Other (not including Serious) AEs in the appropriate table. Therefore, the Other AEs table includes a combined set of serious and non-serious AEs.
|
0.00%
0/69 • Within 30 days after stopping study treatment or any SAE that the study investigator felt was study treatment related.
Other Adverse Events(AEs) are at least possibly related to study treatment. Due to the methods in which adverse events were collected and/or stored for this study, it is not possible to report only the Other (not including Serious) AEs in the appropriate table. Therefore, the Other AEs table includes a combined set of serious and non-serious AEs.
|
|
Blood and lymphatic system disorders
Edema
|
1.5%
1/67 • Within 30 days after stopping study treatment or any SAE that the study investigator felt was study treatment related.
Other Adverse Events(AEs) are at least possibly related to study treatment. Due to the methods in which adverse events were collected and/or stored for this study, it is not possible to report only the Other (not including Serious) AEs in the appropriate table. Therefore, the Other AEs table includes a combined set of serious and non-serious AEs.
|
0.00%
0/69 • Within 30 days after stopping study treatment or any SAE that the study investigator felt was study treatment related.
Other Adverse Events(AEs) are at least possibly related to study treatment. Due to the methods in which adverse events were collected and/or stored for this study, it is not possible to report only the Other (not including Serious) AEs in the appropriate table. Therefore, the Other AEs table includes a combined set of serious and non-serious AEs.
|
|
Nervous system disorders
Neuropathy - motor
|
1.5%
1/67 • Within 30 days after stopping study treatment or any SAE that the study investigator felt was study treatment related.
Other Adverse Events(AEs) are at least possibly related to study treatment. Due to the methods in which adverse events were collected and/or stored for this study, it is not possible to report only the Other (not including Serious) AEs in the appropriate table. Therefore, the Other AEs table includes a combined set of serious and non-serious AEs.
|
0.00%
0/69 • Within 30 days after stopping study treatment or any SAE that the study investigator felt was study treatment related.
Other Adverse Events(AEs) are at least possibly related to study treatment. Due to the methods in which adverse events were collected and/or stored for this study, it is not possible to report only the Other (not including Serious) AEs in the appropriate table. Therefore, the Other AEs table includes a combined set of serious and non-serious AEs.
|
|
Nervous system disorders
Tremor
|
1.5%
1/67 • Within 30 days after stopping study treatment or any SAE that the study investigator felt was study treatment related.
Other Adverse Events(AEs) are at least possibly related to study treatment. Due to the methods in which adverse events were collected and/or stored for this study, it is not possible to report only the Other (not including Serious) AEs in the appropriate table. Therefore, the Other AEs table includes a combined set of serious and non-serious AEs.
|
0.00%
0/69 • Within 30 days after stopping study treatment or any SAE that the study investigator felt was study treatment related.
Other Adverse Events(AEs) are at least possibly related to study treatment. Due to the methods in which adverse events were collected and/or stored for this study, it is not possible to report only the Other (not including Serious) AEs in the appropriate table. Therefore, the Other AEs table includes a combined set of serious and non-serious AEs.
|
|
Nervous system disorders
Dizziness/lightheadedness
|
1.5%
1/67 • Within 30 days after stopping study treatment or any SAE that the study investigator felt was study treatment related.
Other Adverse Events(AEs) are at least possibly related to study treatment. Due to the methods in which adverse events were collected and/or stored for this study, it is not possible to report only the Other (not including Serious) AEs in the appropriate table. Therefore, the Other AEs table includes a combined set of serious and non-serious AEs.
|
0.00%
0/69 • Within 30 days after stopping study treatment or any SAE that the study investigator felt was study treatment related.
Other Adverse Events(AEs) are at least possibly related to study treatment. Due to the methods in which adverse events were collected and/or stored for this study, it is not possible to report only the Other (not including Serious) AEs in the appropriate table. Therefore, the Other AEs table includes a combined set of serious and non-serious AEs.
|
|
General disorders
Fatigue
|
1.5%
1/67 • Within 30 days after stopping study treatment or any SAE that the study investigator felt was study treatment related.
Other Adverse Events(AEs) are at least possibly related to study treatment. Due to the methods in which adverse events were collected and/or stored for this study, it is not possible to report only the Other (not including Serious) AEs in the appropriate table. Therefore, the Other AEs table includes a combined set of serious and non-serious AEs.
|
0.00%
0/69 • Within 30 days after stopping study treatment or any SAE that the study investigator felt was study treatment related.
Other Adverse Events(AEs) are at least possibly related to study treatment. Due to the methods in which adverse events were collected and/or stored for this study, it is not possible to report only the Other (not including Serious) AEs in the appropriate table. Therefore, the Other AEs table includes a combined set of serious and non-serious AEs.
|
Other adverse events
| Measure |
Grp - 1
n=67 participants at risk
Thalidomide 200mg orally daily with weekly escalation of 100mg to a maximum dose of 400mg until progression or additional therapy prohibited further therapy.
|
Grp - 2
n=69 participants at risk
Tamoxifen 20mg orally for up to 12 28-day cycles until progression or adverse effect prohibited additional therapy.
|
|---|---|---|
|
Blood and lymphatic system disorders
Leukopenia
|
37.3%
25/67 • Within 30 days after stopping study treatment or any SAE that the study investigator felt was study treatment related.
Other Adverse Events(AEs) are at least possibly related to study treatment. Due to the methods in which adverse events were collected and/or stored for this study, it is not possible to report only the Other (not including Serious) AEs in the appropriate table. Therefore, the Other AEs table includes a combined set of serious and non-serious AEs.
|
11.6%
8/69 • Within 30 days after stopping study treatment or any SAE that the study investigator felt was study treatment related.
Other Adverse Events(AEs) are at least possibly related to study treatment. Due to the methods in which adverse events were collected and/or stored for this study, it is not possible to report only the Other (not including Serious) AEs in the appropriate table. Therefore, the Other AEs table includes a combined set of serious and non-serious AEs.
|
|
Blood and lymphatic system disorders
Neutropenia
|
31.3%
21/67 • Within 30 days after stopping study treatment or any SAE that the study investigator felt was study treatment related.
Other Adverse Events(AEs) are at least possibly related to study treatment. Due to the methods in which adverse events were collected and/or stored for this study, it is not possible to report only the Other (not including Serious) AEs in the appropriate table. Therefore, the Other AEs table includes a combined set of serious and non-serious AEs.
|
7.2%
5/69 • Within 30 days after stopping study treatment or any SAE that the study investigator felt was study treatment related.
Other Adverse Events(AEs) are at least possibly related to study treatment. Due to the methods in which adverse events were collected and/or stored for this study, it is not possible to report only the Other (not including Serious) AEs in the appropriate table. Therefore, the Other AEs table includes a combined set of serious and non-serious AEs.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
9.0%
6/67 • Within 30 days after stopping study treatment or any SAE that the study investigator felt was study treatment related.
Other Adverse Events(AEs) are at least possibly related to study treatment. Due to the methods in which adverse events were collected and/or stored for this study, it is not possible to report only the Other (not including Serious) AEs in the appropriate table. Therefore, the Other AEs table includes a combined set of serious and non-serious AEs.
|
5.8%
4/69 • Within 30 days after stopping study treatment or any SAE that the study investigator felt was study treatment related.
Other Adverse Events(AEs) are at least possibly related to study treatment. Due to the methods in which adverse events were collected and/or stored for this study, it is not possible to report only the Other (not including Serious) AEs in the appropriate table. Therefore, the Other AEs table includes a combined set of serious and non-serious AEs.
|
|
Blood and lymphatic system disorders
Anemia
|
22.4%
15/67 • Within 30 days after stopping study treatment or any SAE that the study investigator felt was study treatment related.
Other Adverse Events(AEs) are at least possibly related to study treatment. Due to the methods in which adverse events were collected and/or stored for this study, it is not possible to report only the Other (not including Serious) AEs in the appropriate table. Therefore, the Other AEs table includes a combined set of serious and non-serious AEs.
|
14.5%
10/69 • Within 30 days after stopping study treatment or any SAE that the study investigator felt was study treatment related.
Other Adverse Events(AEs) are at least possibly related to study treatment. Due to the methods in which adverse events were collected and/or stored for this study, it is not possible to report only the Other (not including Serious) AEs in the appropriate table. Therefore, the Other AEs table includes a combined set of serious and non-serious AEs.
|
|
Cardiac disorders
DVT/thrombosis
|
6.0%
4/67 • Within 30 days after stopping study treatment or any SAE that the study investigator felt was study treatment related.
Other Adverse Events(AEs) are at least possibly related to study treatment. Due to the methods in which adverse events were collected and/or stored for this study, it is not possible to report only the Other (not including Serious) AEs in the appropriate table. Therefore, the Other AEs table includes a combined set of serious and non-serious AEs.
|
1.4%
1/69 • Within 30 days after stopping study treatment or any SAE that the study investigator felt was study treatment related.
Other Adverse Events(AEs) are at least possibly related to study treatment. Due to the methods in which adverse events were collected and/or stored for this study, it is not possible to report only the Other (not including Serious) AEs in the appropriate table. Therefore, the Other AEs table includes a combined set of serious and non-serious AEs.
|
|
Cardiac disorders
Other cardiovascular
|
16.4%
11/67 • Within 30 days after stopping study treatment or any SAE that the study investigator felt was study treatment related.
Other Adverse Events(AEs) are at least possibly related to study treatment. Due to the methods in which adverse events were collected and/or stored for this study, it is not possible to report only the Other (not including Serious) AEs in the appropriate table. Therefore, the Other AEs table includes a combined set of serious and non-serious AEs.
|
8.7%
6/69 • Within 30 days after stopping study treatment or any SAE that the study investigator felt was study treatment related.
Other Adverse Events(AEs) are at least possibly related to study treatment. Due to the methods in which adverse events were collected and/or stored for this study, it is not possible to report only the Other (not including Serious) AEs in the appropriate table. Therefore, the Other AEs table includes a combined set of serious and non-serious AEs.
|
|
General disorders
Constitutional
|
62.7%
42/67 • Within 30 days after stopping study treatment or any SAE that the study investigator felt was study treatment related.
Other Adverse Events(AEs) are at least possibly related to study treatment. Due to the methods in which adverse events were collected and/or stored for this study, it is not possible to report only the Other (not including Serious) AEs in the appropriate table. Therefore, the Other AEs table includes a combined set of serious and non-serious AEs.
|
26.1%
18/69 • Within 30 days after stopping study treatment or any SAE that the study investigator felt was study treatment related.
Other Adverse Events(AEs) are at least possibly related to study treatment. Due to the methods in which adverse events were collected and/or stored for this study, it is not possible to report only the Other (not including Serious) AEs in the appropriate table. Therefore, the Other AEs table includes a combined set of serious and non-serious AEs.
|
|
Skin and subcutaneous tissue disorders
Dermatologic
|
32.8%
22/67 • Within 30 days after stopping study treatment or any SAE that the study investigator felt was study treatment related.
Other Adverse Events(AEs) are at least possibly related to study treatment. Due to the methods in which adverse events were collected and/or stored for this study, it is not possible to report only the Other (not including Serious) AEs in the appropriate table. Therefore, the Other AEs table includes a combined set of serious and non-serious AEs.
|
5.8%
4/69 • Within 30 days after stopping study treatment or any SAE that the study investigator felt was study treatment related.
Other Adverse Events(AEs) are at least possibly related to study treatment. Due to the methods in which adverse events were collected and/or stored for this study, it is not possible to report only the Other (not including Serious) AEs in the appropriate table. Therefore, the Other AEs table includes a combined set of serious and non-serious AEs.
|
|
Endocrine disorders
Endocrine
|
1.5%
1/67 • Within 30 days after stopping study treatment or any SAE that the study investigator felt was study treatment related.
Other Adverse Events(AEs) are at least possibly related to study treatment. Due to the methods in which adverse events were collected and/or stored for this study, it is not possible to report only the Other (not including Serious) AEs in the appropriate table. Therefore, the Other AEs table includes a combined set of serious and non-serious AEs.
|
34.8%
24/69 • Within 30 days after stopping study treatment or any SAE that the study investigator felt was study treatment related.
Other Adverse Events(AEs) are at least possibly related to study treatment. Due to the methods in which adverse events were collected and/or stored for this study, it is not possible to report only the Other (not including Serious) AEs in the appropriate table. Therefore, the Other AEs table includes a combined set of serious and non-serious AEs.
|
|
Gastrointestinal disorders
Gastrointestinal
|
62.7%
42/67 • Within 30 days after stopping study treatment or any SAE that the study investigator felt was study treatment related.
Other Adverse Events(AEs) are at least possibly related to study treatment. Due to the methods in which adverse events were collected and/or stored for this study, it is not possible to report only the Other (not including Serious) AEs in the appropriate table. Therefore, the Other AEs table includes a combined set of serious and non-serious AEs.
|
31.9%
22/69 • Within 30 days after stopping study treatment or any SAE that the study investigator felt was study treatment related.
Other Adverse Events(AEs) are at least possibly related to study treatment. Due to the methods in which adverse events were collected and/or stored for this study, it is not possible to report only the Other (not including Serious) AEs in the appropriate table. Therefore, the Other AEs table includes a combined set of serious and non-serious AEs.
|
|
Reproductive system and breast disorders
Genitourinary/renal
|
4.5%
3/67 • Within 30 days after stopping study treatment or any SAE that the study investigator felt was study treatment related.
Other Adverse Events(AEs) are at least possibly related to study treatment. Due to the methods in which adverse events were collected and/or stored for this study, it is not possible to report only the Other (not including Serious) AEs in the appropriate table. Therefore, the Other AEs table includes a combined set of serious and non-serious AEs.
|
7.2%
5/69 • Within 30 days after stopping study treatment or any SAE that the study investigator felt was study treatment related.
Other Adverse Events(AEs) are at least possibly related to study treatment. Due to the methods in which adverse events were collected and/or stored for this study, it is not possible to report only the Other (not including Serious) AEs in the appropriate table. Therefore, the Other AEs table includes a combined set of serious and non-serious AEs.
|
|
Metabolism and nutrition disorders
Metabolic
|
11.9%
8/67 • Within 30 days after stopping study treatment or any SAE that the study investigator felt was study treatment related.
Other Adverse Events(AEs) are at least possibly related to study treatment. Due to the methods in which adverse events were collected and/or stored for this study, it is not possible to report only the Other (not including Serious) AEs in the appropriate table. Therefore, the Other AEs table includes a combined set of serious and non-serious AEs.
|
11.6%
8/69 • Within 30 days after stopping study treatment or any SAE that the study investigator felt was study treatment related.
Other Adverse Events(AEs) are at least possibly related to study treatment. Due to the methods in which adverse events were collected and/or stored for this study, it is not possible to report only the Other (not including Serious) AEs in the appropriate table. Therefore, the Other AEs table includes a combined set of serious and non-serious AEs.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal
|
3.0%
2/67 • Within 30 days after stopping study treatment or any SAE that the study investigator felt was study treatment related.
Other Adverse Events(AEs) are at least possibly related to study treatment. Due to the methods in which adverse events were collected and/or stored for this study, it is not possible to report only the Other (not including Serious) AEs in the appropriate table. Therefore, the Other AEs table includes a combined set of serious and non-serious AEs.
|
5.8%
4/69 • Within 30 days after stopping study treatment or any SAE that the study investigator felt was study treatment related.
Other Adverse Events(AEs) are at least possibly related to study treatment. Due to the methods in which adverse events were collected and/or stored for this study, it is not possible to report only the Other (not including Serious) AEs in the appropriate table. Therefore, the Other AEs table includes a combined set of serious and non-serious AEs.
|
|
Nervous system disorders
Somnolence
|
25.4%
17/67 • Within 30 days after stopping study treatment or any SAE that the study investigator felt was study treatment related.
Other Adverse Events(AEs) are at least possibly related to study treatment. Due to the methods in which adverse events were collected and/or stored for this study, it is not possible to report only the Other (not including Serious) AEs in the appropriate table. Therefore, the Other AEs table includes a combined set of serious and non-serious AEs.
|
0.00%
0/69 • Within 30 days after stopping study treatment or any SAE that the study investigator felt was study treatment related.
Other Adverse Events(AEs) are at least possibly related to study treatment. Due to the methods in which adverse events were collected and/or stored for this study, it is not possible to report only the Other (not including Serious) AEs in the appropriate table. Therefore, the Other AEs table includes a combined set of serious and non-serious AEs.
|
|
Nervous system disorders
Other neurologic
|
47.8%
32/67 • Within 30 days after stopping study treatment or any SAE that the study investigator felt was study treatment related.
Other Adverse Events(AEs) are at least possibly related to study treatment. Due to the methods in which adverse events were collected and/or stored for this study, it is not possible to report only the Other (not including Serious) AEs in the appropriate table. Therefore, the Other AEs table includes a combined set of serious and non-serious AEs.
|
2.9%
2/69 • Within 30 days after stopping study treatment or any SAE that the study investigator felt was study treatment related.
Other Adverse Events(AEs) are at least possibly related to study treatment. Due to the methods in which adverse events were collected and/or stored for this study, it is not possible to report only the Other (not including Serious) AEs in the appropriate table. Therefore, the Other AEs table includes a combined set of serious and non-serious AEs.
|
|
Nervous system disorders
Peripheral neurologic
|
47.8%
32/67 • Within 30 days after stopping study treatment or any SAE that the study investigator felt was study treatment related.
Other Adverse Events(AEs) are at least possibly related to study treatment. Due to the methods in which adverse events were collected and/or stored for this study, it is not possible to report only the Other (not including Serious) AEs in the appropriate table. Therefore, the Other AEs table includes a combined set of serious and non-serious AEs.
|
13.0%
9/69 • Within 30 days after stopping study treatment or any SAE that the study investigator felt was study treatment related.
Other Adverse Events(AEs) are at least possibly related to study treatment. Due to the methods in which adverse events were collected and/or stored for this study, it is not possible to report only the Other (not including Serious) AEs in the appropriate table. Therefore, the Other AEs table includes a combined set of serious and non-serious AEs.
|
|
Eye disorders
Ocular/visual
|
16.4%
11/67 • Within 30 days after stopping study treatment or any SAE that the study investigator felt was study treatment related.
Other Adverse Events(AEs) are at least possibly related to study treatment. Due to the methods in which adverse events were collected and/or stored for this study, it is not possible to report only the Other (not including Serious) AEs in the appropriate table. Therefore, the Other AEs table includes a combined set of serious and non-serious AEs.
|
2.9%
2/69 • Within 30 days after stopping study treatment or any SAE that the study investigator felt was study treatment related.
Other Adverse Events(AEs) are at least possibly related to study treatment. Due to the methods in which adverse events were collected and/or stored for this study, it is not possible to report only the Other (not including Serious) AEs in the appropriate table. Therefore, the Other AEs table includes a combined set of serious and non-serious AEs.
|
|
General disorders
Pain
|
38.8%
26/67 • Within 30 days after stopping study treatment or any SAE that the study investigator felt was study treatment related.
Other Adverse Events(AEs) are at least possibly related to study treatment. Due to the methods in which adverse events were collected and/or stored for this study, it is not possible to report only the Other (not including Serious) AEs in the appropriate table. Therefore, the Other AEs table includes a combined set of serious and non-serious AEs.
|
27.5%
19/69 • Within 30 days after stopping study treatment or any SAE that the study investigator felt was study treatment related.
Other Adverse Events(AEs) are at least possibly related to study treatment. Due to the methods in which adverse events were collected and/or stored for this study, it is not possible to report only the Other (not including Serious) AEs in the appropriate table. Therefore, the Other AEs table includes a combined set of serious and non-serious AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary
|
16.4%
11/67 • Within 30 days after stopping study treatment or any SAE that the study investigator felt was study treatment related.
Other Adverse Events(AEs) are at least possibly related to study treatment. Due to the methods in which adverse events were collected and/or stored for this study, it is not possible to report only the Other (not including Serious) AEs in the appropriate table. Therefore, the Other AEs table includes a combined set of serious and non-serious AEs.
|
1.4%
1/69 • Within 30 days after stopping study treatment or any SAE that the study investigator felt was study treatment related.
Other Adverse Events(AEs) are at least possibly related to study treatment. Due to the methods in which adverse events were collected and/or stored for this study, it is not possible to report only the Other (not including Serious) AEs in the appropriate table. Therefore, the Other AEs table includes a combined set of serious and non-serious AEs.
|
Additional Information
Melissa Leventhal
Gynecologic Oncology Group (GOG) Statistical and Data Center
Phone: 716-845-4030
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60