Trial Outcomes & Findings for Prasterone (Dehydroepiandrosterone) in Treating Postmenopausal Cancer Survivors With Vaginal Symptoms (NCT NCT01376349)

Last Updated: 2019-02-07

Results Overview

The primary outcome is severity of the most bothersome vaginal symptom: dryness or dyspareunia. The Vaginal Symptom Measure (VSM) was used to evaluate the severity of vaginal dryness and dyspareunia. The VSM uses a 5- point ordinal response scale; 1="none", 2="mild", 3="moderate", 4="severe" and 5="very severe" to measure the severity associated with vaginal dryness and/or dyspareunia. For each patient, the change in severity was calculated by subtracting the baseline from the week 12 reported score. Therefore, the full range of scores ranges from -4 (greatest decrease in severity) to 4 (greatest increase in severity). A negative score indicates a decrease in severity from baseline, zero indicates no reported affect and positive scores indicate a more severe report at week 12. The primary assessment method will be a comparison of the averages of the changes over time in the severity items for the most bothersome symptom from baseline to 12 weeks (as indicated at baseline).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

464 participants

Primary outcome timeframe

At baseline and 12 weeks

Results posted on

2019-02-07

Participant Flow

A total of 464 patients were accrued to this trial. Nineteen patients withdrew consent prior to randomization and were not included in the analysis of this study. Two additional patients were unable to classify the primary symptom and were not randomized to the trial and were not included in the analysis.

Participant milestones

Participant milestones
Measure	Arm I Low Dose DHEA Participants apply a low dose (3.25 mg) of vaginal prasterone (dehydroepiandrosterone \[DHEA\]) gel once daily (QD), at bed time, for 12 weeks. Treatment continues until unacceptable adverse events or patient refusal to continue participation on the study.	Arm II High Dose DHEA Participants apply a high dose (6.5 mg) of vaginal DHEA gel QD, at bed time, for 12 weeks. Treatment continues until unacceptable adverse events or patient refusal to continue participation on the study.	Arm III Placebo Participants apply a vaginal placebo gel QD, at bed time, for 12 weeks. There is an Optional Continuation Phase (for placebo arm only): Participants apply a high dose of vaginal DHEA gel QD, at bed time, for 12 weeks. Treatment continues until unacceptable adverse events or patient refusal to continue participation on the study.
Raondomized Treatment STARTED	147	149	147
Raondomized Treatment COMPLETED	123	114	118
Raondomized Treatment NOT COMPLETED	24	35	29
Optional Continuation Phase STARTED	0	0	94
Optional Continuation Phase COMPLETED	0	0	94
Optional Continuation Phase NOT COMPLETED	0	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Arm I Low Dose DHEA Participants apply a low dose (3.25 mg) of vaginal prasterone (dehydroepiandrosterone \[DHEA\]) gel once daily (QD), at bed time, for 12 weeks. Treatment continues until unacceptable adverse events or patient refusal to continue participation on the study.	Arm II High Dose DHEA Participants apply a high dose (6.5 mg) of vaginal DHEA gel QD, at bed time, for 12 weeks. Treatment continues until unacceptable adverse events or patient refusal to continue participation on the study.	Arm III Placebo Participants apply a vaginal placebo gel QD, at bed time, for 12 weeks. There is an Optional Continuation Phase (for placebo arm only): Participants apply a high dose of vaginal DHEA gel QD, at bed time, for 12 weeks. Treatment continues until unacceptable adverse events or patient refusal to continue participation on the study.
Raondomized Treatment Withdrawal by Subject	10	16	13
Raondomized Treatment Adverse Event	13	17	14
Raondomized Treatment Unkown	1	2	1
Raondomized Treatment Alternative Treatment	0	0	1

Baseline Characteristics

Prasterone (Dehydroepiandrosterone) in Treating Postmenopausal Cancer Survivors With Vaginal Symptoms

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm I Low Dose DHEA n=147 Participants Participants apply a low dose (3.25 mg) of vaginal prasterone (dehydroepiandrosterone \[DHEA\]) gel once daily (QD), at bed time, for 12 weeks. Treatment continues until unacceptable adverse events or patient refusal to continue participation on the study.	Arm II High Dose DHEA n=149 Participants Participants apply a high dose (6.5 mg) of vaginal DHEA gel QD, at bed time, for 12 weeks. Treatment continues until unacceptable adverse events or patient refusal to continue participation on the study.	Arm III Placebo n=147 Participants Participants apply a vaginal placebo gel QD, at bed time, for 12 weeks. \> \> There is an Optional Continuation Phase (for placebo arm only): Participants apply a high dose of vaginal DHEA gel QD, at bed time, for 12 weeks. Treatment continues until unacceptable adverse events or patient refusal to continue participation on the study.	Total n=443 Participants Total of all reporting groups
Age, Continuous	56.8 years STANDARD_DEVIATION 6.7 • n=93 Participants	57.3 years STANDARD_DEVIATION 8.2 • n=4 Participants	58 years STANDARD_DEVIATION 7.3 • n=27 Participants	57.3 years STANDARD_DEVIATION 7.4 • n=483 Participants
Sex: Female, Male Female	147 Participants n=93 Participants	149 Participants n=4 Participants	147 Participants n=27 Participants	443 Participants n=483 Participants
Sex: Female, Male Male	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Region of Enrollment United States	147 participants n=93 Participants	149 participants n=4 Participants	147 participants n=27 Participants	443 participants n=483 Participants

PRIMARY outcome

Timeframe: At baseline and 12 weeks

Population: All patients that started treatment and completed their week 12 evaluation are included in this analysis.

Outcome measures

Outcome measures
Measure	Arm I Low Dose DHEA n=123 Participants Participants apply a low dose (3.25 mg) of vaginal prasterone (dehydroepiandrosterone \[DHEA\]) gel once daily (QD), at bed time, for 12 weeks. Treatment continues until unacceptable adverse events or patient refusal to continue participation on the study.	Arm II High Dose DHEA n=114 Participants Participants apply a high dose (6.5 mg) of vaginal DHEA gel QD, at bed time, for 12 weeks. Treatment continues until unacceptable adverse events or patient refusal to continue participation on the study.	Arm III Placebo n=118 Participants Participants apply a vaginal placebo gel QD, at bed time, for 12 weeks. There is an Optional Continuation Phase (for placebo arm only): Participants apply a high dose of vaginal DHEA gel QD, at bed time, for 12 weeks. Treatment continues until unacceptable adverse events or patient refusal to continue participation on the study.
Alleviation of the Most Bothersome Vaginal Symptom (Vaginal Dryness or Dyspareunia) Over 12 Weeks	-2 change in units on a scale Interval -4.0 to 1.0	-2 change in units on a scale Interval -4.0 to 1.0	-1 change in units on a scale Interval -4.0 to 1.0

Adverse Events

Arm I: Low Dose DHEA

Serious events: 3 serious events

Other events: 91 other events

Deaths: 0 deaths

Arm II: High Dose DHEA

Serious events: 7 serious events

Other events: 105 other events

Deaths: 0 deaths

Arm III: Placebo

Serious events: 4 serious events

Other events: 93 other events

Deaths: 0 deaths

Optional Continuation Phase

Serious events: 0 serious events

Other events: 28 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Arm I: Low Dose DHEA n=147 participants at risk Participants apply a low dose (3.25 mg) of vaginal prasterone (dehydroepiandrosterone \[DHEA\]) gel once daily (QD), at bed time, for 12 weeks. Treatment continues until unacceptable adverse events or patient refusal to continue participation on the study.	Arm II: High Dose DHEA n=148 participants at risk Participants apply a high dose (6.5 mg) of vaginal DHEA gel QD, at bed time, for 12 weeks. Treatment continues until unacceptable adverse events or patient refusal to continue participation on the study.	Arm III: Placebo n=147 participants at risk Participants apply a vaginal placebo gel QD, at bed time, for 12 weeks. There is an Optional Continuation Phase (for placebo arm only): Participants apply a high dose of vaginal DHEA gel QD, at bed time, for 12 weeks. Treatment continues until unacceptable adverse events or patient refusal to continue participation on the study.	Optional Continuation Phase n=94 participants at risk Patients randomized to Arm III Placebo who have completed protocol treatment for 12 weeks were offered the option of continuing treatment according to Arm II High Dose DHEA until unacceptable adverse events or patient refusal to continue participation on the study. 94 of the 147 patients randomized to the Placebo arm opted to continue treatment with High Dose DHEA.
Infections and infestations Bladder infection	0.68% 1/147 • Number of events 1 All patients that started treatment and were assessed for adverse events were included in this section. This includes all 147 patients from Arm I, 148 patients from Arm II (one patient was not assessed for Adverse Events), and 147 patients from Arm III. In addition, patients from Arm III: Placebo were given the opportunity to receive treatment according to the Arm II: High Dose schedule upon completion of 12 weeks. 94 of the 147 patients randomized to Arm III opted to continue treatment.	0.00% 0/148 All patients that started treatment and were assessed for adverse events were included in this section. This includes all 147 patients from Arm I, 148 patients from Arm II (one patient was not assessed for Adverse Events), and 147 patients from Arm III. In addition, patients from Arm III: Placebo were given the opportunity to receive treatment according to the Arm II: High Dose schedule upon completion of 12 weeks. 94 of the 147 patients randomized to Arm III opted to continue treatment.	0.00% 0/147 All patients that started treatment and were assessed for adverse events were included in this section. This includes all 147 patients from Arm I, 148 patients from Arm II (one patient was not assessed for Adverse Events), and 147 patients from Arm III. In addition, patients from Arm III: Placebo were given the opportunity to receive treatment according to the Arm II: High Dose schedule upon completion of 12 weeks. 94 of the 147 patients randomized to Arm III opted to continue treatment.	0.00% 0/94 All patients that started treatment and were assessed for adverse events were included in this section. This includes all 147 patients from Arm I, 148 patients from Arm II (one patient was not assessed for Adverse Events), and 147 patients from Arm III. In addition, patients from Arm III: Placebo were given the opportunity to receive treatment according to the Arm II: High Dose schedule upon completion of 12 weeks. 94 of the 147 patients randomized to Arm III opted to continue treatment.
Infections and infestations Breast infection	0.00% 0/147 All patients that started treatment and were assessed for adverse events were included in this section. This includes all 147 patients from Arm I, 148 patients from Arm II (one patient was not assessed for Adverse Events), and 147 patients from Arm III. In addition, patients from Arm III: Placebo were given the opportunity to receive treatment according to the Arm II: High Dose schedule upon completion of 12 weeks. 94 of the 147 patients randomized to Arm III opted to continue treatment.	0.00% 0/148 All patients that started treatment and were assessed for adverse events were included in this section. This includes all 147 patients from Arm I, 148 patients from Arm II (one patient was not assessed for Adverse Events), and 147 patients from Arm III. In addition, patients from Arm III: Placebo were given the opportunity to receive treatment according to the Arm II: High Dose schedule upon completion of 12 weeks. 94 of the 147 patients randomized to Arm III opted to continue treatment.	0.68% 1/147 • Number of events 1 All patients that started treatment and were assessed for adverse events were included in this section. This includes all 147 patients from Arm I, 148 patients from Arm II (one patient was not assessed for Adverse Events), and 147 patients from Arm III. In addition, patients from Arm III: Placebo were given the opportunity to receive treatment according to the Arm II: High Dose schedule upon completion of 12 weeks. 94 of the 147 patients randomized to Arm III opted to continue treatment.	0.00% 0/94 All patients that started treatment and were assessed for adverse events were included in this section. This includes all 147 patients from Arm I, 148 patients from Arm II (one patient was not assessed for Adverse Events), and 147 patients from Arm III. In addition, patients from Arm III: Placebo were given the opportunity to receive treatment according to the Arm II: High Dose schedule upon completion of 12 weeks. 94 of the 147 patients randomized to Arm III opted to continue treatment.
Infections and infestations Urinary tract infection	0.00% 0/147 All patients that started treatment and were assessed for adverse events were included in this section. This includes all 147 patients from Arm I, 148 patients from Arm II (one patient was not assessed for Adverse Events), and 147 patients from Arm III. In addition, patients from Arm III: Placebo were given the opportunity to receive treatment according to the Arm II: High Dose schedule upon completion of 12 weeks. 94 of the 147 patients randomized to Arm III opted to continue treatment.	0.00% 0/148 All patients that started treatment and were assessed for adverse events were included in this section. This includes all 147 patients from Arm I, 148 patients from Arm II (one patient was not assessed for Adverse Events), and 147 patients from Arm III. In addition, patients from Arm III: Placebo were given the opportunity to receive treatment according to the Arm II: High Dose schedule upon completion of 12 weeks. 94 of the 147 patients randomized to Arm III opted to continue treatment.	0.68% 1/147 • Number of events 1 All patients that started treatment and were assessed for adverse events were included in this section. This includes all 147 patients from Arm I, 148 patients from Arm II (one patient was not assessed for Adverse Events), and 147 patients from Arm III. In addition, patients from Arm III: Placebo were given the opportunity to receive treatment according to the Arm II: High Dose schedule upon completion of 12 weeks. 94 of the 147 patients randomized to Arm III opted to continue treatment.	0.00% 0/94 All patients that started treatment and were assessed for adverse events were included in this section. This includes all 147 patients from Arm I, 148 patients from Arm II (one patient was not assessed for Adverse Events), and 147 patients from Arm III. In addition, patients from Arm III: Placebo were given the opportunity to receive treatment according to the Arm II: High Dose schedule upon completion of 12 weeks. 94 of the 147 patients randomized to Arm III opted to continue treatment.
Infections and infestations Vaginal infection	0.68% 1/147 • Number of events 1 All patients that started treatment and were assessed for adverse events were included in this section. This includes all 147 patients from Arm I, 148 patients from Arm II (one patient was not assessed for Adverse Events), and 147 patients from Arm III. In addition, patients from Arm III: Placebo were given the opportunity to receive treatment according to the Arm II: High Dose schedule upon completion of 12 weeks. 94 of the 147 patients randomized to Arm III opted to continue treatment.	0.68% 1/148 • Number of events 1 All patients that started treatment and were assessed for adverse events were included in this section. This includes all 147 patients from Arm I, 148 patients from Arm II (one patient was not assessed for Adverse Events), and 147 patients from Arm III. In addition, patients from Arm III: Placebo were given the opportunity to receive treatment according to the Arm II: High Dose schedule upon completion of 12 weeks. 94 of the 147 patients randomized to Arm III opted to continue treatment.	0.68% 1/147 • Number of events 1 All patients that started treatment and were assessed for adverse events were included in this section. This includes all 147 patients from Arm I, 148 patients from Arm II (one patient was not assessed for Adverse Events), and 147 patients from Arm III. In addition, patients from Arm III: Placebo were given the opportunity to receive treatment according to the Arm II: High Dose schedule upon completion of 12 weeks. 94 of the 147 patients randomized to Arm III opted to continue treatment.	0.00% 0/94 All patients that started treatment and were assessed for adverse events were included in this section. This includes all 147 patients from Arm I, 148 patients from Arm II (one patient was not assessed for Adverse Events), and 147 patients from Arm III. In addition, patients from Arm III: Placebo were given the opportunity to receive treatment according to the Arm II: High Dose schedule upon completion of 12 weeks. 94 of the 147 patients randomized to Arm III opted to continue treatment.
Investigations Investigations - Other, specify	0.00% 0/147 All patients that started treatment and were assessed for adverse events were included in this section. This includes all 147 patients from Arm I, 148 patients from Arm II (one patient was not assessed for Adverse Events), and 147 patients from Arm III. In addition, patients from Arm III: Placebo were given the opportunity to receive treatment according to the Arm II: High Dose schedule upon completion of 12 weeks. 94 of the 147 patients randomized to Arm III opted to continue treatment.	0.68% 1/148 • Number of events 1 All patients that started treatment and were assessed for adverse events were included in this section. This includes all 147 patients from Arm I, 148 patients from Arm II (one patient was not assessed for Adverse Events), and 147 patients from Arm III. In addition, patients from Arm III: Placebo were given the opportunity to receive treatment according to the Arm II: High Dose schedule upon completion of 12 weeks. 94 of the 147 patients randomized to Arm III opted to continue treatment.	0.00% 0/147 All patients that started treatment and were assessed for adverse events were included in this section. This includes all 147 patients from Arm I, 148 patients from Arm II (one patient was not assessed for Adverse Events), and 147 patients from Arm III. In addition, patients from Arm III: Placebo were given the opportunity to receive treatment according to the Arm II: High Dose schedule upon completion of 12 weeks. 94 of the 147 patients randomized to Arm III opted to continue treatment.	0.00% 0/94 All patients that started treatment and were assessed for adverse events were included in this section. This includes all 147 patients from Arm I, 148 patients from Arm II (one patient was not assessed for Adverse Events), and 147 patients from Arm III. In addition, patients from Arm III: Placebo were given the opportunity to receive treatment according to the Arm II: High Dose schedule upon completion of 12 weeks. 94 of the 147 patients randomized to Arm III opted to continue treatment.
Nervous system disorders Headache	0.68% 1/147 • Number of events 1 All patients that started treatment and were assessed for adverse events were included in this section. This includes all 147 patients from Arm I, 148 patients from Arm II (one patient was not assessed for Adverse Events), and 147 patients from Arm III. In addition, patients from Arm III: Placebo were given the opportunity to receive treatment according to the Arm II: High Dose schedule upon completion of 12 weeks. 94 of the 147 patients randomized to Arm III opted to continue treatment.	0.68% 1/148 • Number of events 2 All patients that started treatment and were assessed for adverse events were included in this section. This includes all 147 patients from Arm I, 148 patients from Arm II (one patient was not assessed for Adverse Events), and 147 patients from Arm III. In addition, patients from Arm III: Placebo were given the opportunity to receive treatment according to the Arm II: High Dose schedule upon completion of 12 weeks. 94 of the 147 patients randomized to Arm III opted to continue treatment.	0.68% 1/147 • Number of events 1 All patients that started treatment and were assessed for adverse events were included in this section. This includes all 147 patients from Arm I, 148 patients from Arm II (one patient was not assessed for Adverse Events), and 147 patients from Arm III. In addition, patients from Arm III: Placebo were given the opportunity to receive treatment according to the Arm II: High Dose schedule upon completion of 12 weeks. 94 of the 147 patients randomized to Arm III opted to continue treatment.	0.00% 0/94 All patients that started treatment and were assessed for adverse events were included in this section. This includes all 147 patients from Arm I, 148 patients from Arm II (one patient was not assessed for Adverse Events), and 147 patients from Arm III. In addition, patients from Arm III: Placebo were given the opportunity to receive treatment according to the Arm II: High Dose schedule upon completion of 12 weeks. 94 of the 147 patients randomized to Arm III opted to continue treatment.
Reproductive system and breast disorders Breast pain	0.00% 0/147 All patients that started treatment and were assessed for adverse events were included in this section. This includes all 147 patients from Arm I, 148 patients from Arm II (one patient was not assessed for Adverse Events), and 147 patients from Arm III. In addition, patients from Arm III: Placebo were given the opportunity to receive treatment according to the Arm II: High Dose schedule upon completion of 12 weeks. 94 of the 147 patients randomized to Arm III opted to continue treatment.	0.68% 1/148 • Number of events 1 All patients that started treatment and were assessed for adverse events were included in this section. This includes all 147 patients from Arm I, 148 patients from Arm II (one patient was not assessed for Adverse Events), and 147 patients from Arm III. In addition, patients from Arm III: Placebo were given the opportunity to receive treatment according to the Arm II: High Dose schedule upon completion of 12 weeks. 94 of the 147 patients randomized to Arm III opted to continue treatment.	0.00% 0/147 All patients that started treatment and were assessed for adverse events were included in this section. This includes all 147 patients from Arm I, 148 patients from Arm II (one patient was not assessed for Adverse Events), and 147 patients from Arm III. In addition, patients from Arm III: Placebo were given the opportunity to receive treatment according to the Arm II: High Dose schedule upon completion of 12 weeks. 94 of the 147 patients randomized to Arm III opted to continue treatment.	0.00% 0/94 All patients that started treatment and were assessed for adverse events were included in this section. This includes all 147 patients from Arm I, 148 patients from Arm II (one patient was not assessed for Adverse Events), and 147 patients from Arm III. In addition, patients from Arm III: Placebo were given the opportunity to receive treatment according to the Arm II: High Dose schedule upon completion of 12 weeks. 94 of the 147 patients randomized to Arm III opted to continue treatment.
Respiratory, thoracic and mediastinal disorders Voice alteration	0.00% 0/147 All patients that started treatment and were assessed for adverse events were included in this section. This includes all 147 patients from Arm I, 148 patients from Arm II (one patient was not assessed for Adverse Events), and 147 patients from Arm III. In addition, patients from Arm III: Placebo were given the opportunity to receive treatment according to the Arm II: High Dose schedule upon completion of 12 weeks. 94 of the 147 patients randomized to Arm III opted to continue treatment.	0.00% 0/148 All patients that started treatment and were assessed for adverse events were included in this section. This includes all 147 patients from Arm I, 148 patients from Arm II (one patient was not assessed for Adverse Events), and 147 patients from Arm III. In addition, patients from Arm III: Placebo were given the opportunity to receive treatment according to the Arm II: High Dose schedule upon completion of 12 weeks. 94 of the 147 patients randomized to Arm III opted to continue treatment.	0.68% 1/147 • Number of events 1 All patients that started treatment and were assessed for adverse events were included in this section. This includes all 147 patients from Arm I, 148 patients from Arm II (one patient was not assessed for Adverse Events), and 147 patients from Arm III. In addition, patients from Arm III: Placebo were given the opportunity to receive treatment according to the Arm II: High Dose schedule upon completion of 12 weeks. 94 of the 147 patients randomized to Arm III opted to continue treatment.	0.00% 0/94 All patients that started treatment and were assessed for adverse events were included in this section. This includes all 147 patients from Arm I, 148 patients from Arm II (one patient was not assessed for Adverse Events), and 147 patients from Arm III. In addition, patients from Arm III: Placebo were given the opportunity to receive treatment according to the Arm II: High Dose schedule upon completion of 12 weeks. 94 of the 147 patients randomized to Arm III opted to continue treatment.
Skin and subcutaneous tissue disorders Hirsutism	0.00% 0/147 All patients that started treatment and were assessed for adverse events were included in this section. This includes all 147 patients from Arm I, 148 patients from Arm II (one patient was not assessed for Adverse Events), and 147 patients from Arm III. In addition, patients from Arm III: Placebo were given the opportunity to receive treatment according to the Arm II: High Dose schedule upon completion of 12 weeks. 94 of the 147 patients randomized to Arm III opted to continue treatment.	1.4% 2/148 • Number of events 3 All patients that started treatment and were assessed for adverse events were included in this section. This includes all 147 patients from Arm I, 148 patients from Arm II (one patient was not assessed for Adverse Events), and 147 patients from Arm III. In addition, patients from Arm III: Placebo were given the opportunity to receive treatment according to the Arm II: High Dose schedule upon completion of 12 weeks. 94 of the 147 patients randomized to Arm III opted to continue treatment.	0.00% 0/147 All patients that started treatment and were assessed for adverse events were included in this section. This includes all 147 patients from Arm I, 148 patients from Arm II (one patient was not assessed for Adverse Events), and 147 patients from Arm III. In addition, patients from Arm III: Placebo were given the opportunity to receive treatment according to the Arm II: High Dose schedule upon completion of 12 weeks. 94 of the 147 patients randomized to Arm III opted to continue treatment.	0.00% 0/94 All patients that started treatment and were assessed for adverse events were included in this section. This includes all 147 patients from Arm I, 148 patients from Arm II (one patient was not assessed for Adverse Events), and 147 patients from Arm III. In addition, patients from Arm III: Placebo were given the opportunity to receive treatment according to the Arm II: High Dose schedule upon completion of 12 weeks. 94 of the 147 patients randomized to Arm III opted to continue treatment.
Skin and subcutaneous tissue disorders Rash acneiform	0.00% 0/147 All patients that started treatment and were assessed for adverse events were included in this section. This includes all 147 patients from Arm I, 148 patients from Arm II (one patient was not assessed for Adverse Events), and 147 patients from Arm III. In addition, patients from Arm III: Placebo were given the opportunity to receive treatment according to the Arm II: High Dose schedule upon completion of 12 weeks. 94 of the 147 patients randomized to Arm III opted to continue treatment.	0.68% 1/148 • Number of events 1 All patients that started treatment and were assessed for adverse events were included in this section. This includes all 147 patients from Arm I, 148 patients from Arm II (one patient was not assessed for Adverse Events), and 147 patients from Arm III. In addition, patients from Arm III: Placebo were given the opportunity to receive treatment according to the Arm II: High Dose schedule upon completion of 12 weeks. 94 of the 147 patients randomized to Arm III opted to continue treatment.	0.00% 0/147 All patients that started treatment and were assessed for adverse events were included in this section. This includes all 147 patients from Arm I, 148 patients from Arm II (one patient was not assessed for Adverse Events), and 147 patients from Arm III. In addition, patients from Arm III: Placebo were given the opportunity to receive treatment according to the Arm II: High Dose schedule upon completion of 12 weeks. 94 of the 147 patients randomized to Arm III opted to continue treatment.	0.00% 0/94 All patients that started treatment and were assessed for adverse events were included in this section. This includes all 147 patients from Arm I, 148 patients from Arm II (one patient was not assessed for Adverse Events), and 147 patients from Arm III. In addition, patients from Arm III: Placebo were given the opportunity to receive treatment according to the Arm II: High Dose schedule upon completion of 12 weeks. 94 of the 147 patients randomized to Arm III opted to continue treatment.

Other adverse events

Additional Information

Debra Barton, R.N., Ph.D.

Alliance for Clinical Trials in Oncology

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60