Trial Outcomes & Findings for NINDS CRC Chronic Migraine Treatment Trial (NCT NCT00772031)

NCT ID: NCT00772031

Last Updated: 2012-01-24

Results Overview

(Number of moderate to severe headache days (as defined by the International Headache Society Guidelines (2006)) counted over a 28 day diary period at baseline (before treatment with propranolol or placebo)) minus (the number of moderate to severe headache days counted over a 56 day diary period (weeks 16-24 post treatment) divided by 2).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

191 participants

Primary outcome timeframe

Baseline (pre-randomization), months 5 and 6 post randomization

Results posted on

2012-01-24

Participant Flow

Participant milestones

Participant milestones
Measure	Topiramate Plus Propranolol Participants will receive propranolol and topiramate.	Topiramate Plus Placebo Participants will receive a placebo and topiramate.
Overall Study STARTED	96	95
Overall Study COMPLETED	64	52
Overall Study NOT COMPLETED	32	43

Reasons for withdrawal

Reasons for withdrawal
Measure	Topiramate Plus Propranolol Participants will receive propranolol and topiramate.	Topiramate Plus Placebo Participants will receive a placebo and topiramate.
Overall Study Early termination of trial	12	10
Overall Study Lost to Follow-up	20	33

Baseline Characteristics

NINDS CRC Chronic Migraine Treatment Trial

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Topiramate Plus Propranolol n=96 Participants Participants will receive propranolol and topiramate.	Topiramate Plus Placebo n=95 Participants Participants will receive a placebo and topiramate.	Total n=191 Participants Total of all reporting groups
Age, Categorical <=18 years	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	94 Participants n=5 Participants	92 Participants n=7 Participants	186 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Age Continuous	39.8 years STANDARD_DEVIATION 1.09 • n=5 Participants	41.2 years STANDARD_DEVIATION 1.15 • n=7 Participants	40.5 years STANDARD_DEVIATION 0.79 • n=5 Participants
Sex: Female, Male Female	84 Participants n=5 Participants	88 Participants n=7 Participants	172 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants	7 Participants n=7 Participants	19 Participants n=5 Participants
Region of Enrollment United States	96 participants n=5 Participants	95 participants n=7 Participants	191 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline (pre-randomization), months 5 and 6 post randomization

Population: ITT to the extent diary information was available. Available defined as all subjects with 12 or more diary entries between 16 and 24 weeks. Multiple imputation used on all randomized subjects as a sensitivity analysis on the primary outcome.

Outcome measures

Outcome measures
Measure	Topiramate Plus Propranolol n=63 Participants Participants will receive propranolol and topiramate.	Topiramate Plus Placebo n=48 Participants Participants will receive placebo and topiramate.	Topiramate Plus Propranolol, Prior, Stable Topiramate Participants with prior stable topiramate use received propranolol and topiramate.	Topiramate Plus Placebo, Prior, Stable Topiramate Participants with prior stable topiramate use received a placebo and topiramate.
Change in the Number of Moderate to Severe Headache Days Within a 28 Day Average Period in Six Months Compared to Baseline	4.4 Moderate to severe headache days Standard Deviation 5.98	4.7 Moderate to severe headache days Standard Deviation 5.66	—	—

SECONDARY outcome

Timeframe: 6 months post randomization

Population: All subjects randomized with opportunity for 6 month followup. Due to early study termination those who did not have opportunity for 6 month followup at time of study closure were excluded. All lost to followups were counted as failure

Outcome measures

Outcome measures
Measure	Topiramate Plus Propranolol n=84 Participants Participants will receive propranolol and topiramate.	Topiramate Plus Placebo n=82 Participants Participants will receive placebo and topiramate.	Topiramate Plus Propranolol, Prior, Stable Topiramate Participants with prior stable topiramate use received propranolol and topiramate.	Topiramate Plus Placebo, Prior, Stable Topiramate Participants with prior stable topiramate use received a placebo and topiramate.
Number of Subjects Experiencing at Least a 30% Reduction in 28-day Moderate to Severe Headache Days	37 participants	28 participants	—	—

SECONDARY outcome

Timeframe: 6 months

Population: All participants with the opportunity for 6-month follow-up. Due to early study termination some participants were randomized and did not have the opportunity to be followed for six months

Outcome measures

Outcome measures
Measure	Topiramate Plus Propranolol n=84 Participants Participants will receive propranolol and topiramate.	Topiramate Plus Placebo n=82 Participants Participants will receive placebo and topiramate.	Topiramate Plus Propranolol, Prior, Stable Topiramate Participants with prior stable topiramate use received propranolol and topiramate.	Topiramate Plus Placebo, Prior, Stable Topiramate Participants with prior stable topiramate use received a placebo and topiramate.
Number of Subjects Experiencing at Least a 50% Reduction in 28-day Moderate to Severe Headache Days	26 participants	23 participants	—	—

SECONDARY outcome

Timeframe: Baseline and 6 months

Population: The number who completed the Beck's Depression Inventory at baseline and three months

Total score from Beck's Depression Inventory FastScreen at 6 months minus total score from Beck's Depression Inventory FastScreen at baseline. Scale scores range from 0 to 21 with higher values indicating worsening depression. the following categories separate participants into groups of depression levels: Minimal (Score 0-3), Mild (Score 4-8),Moderate (Score 9-12),Severe (Score 13-21).

Outcome measures

Outcome measures
Measure	Topiramate Plus Propranolol n=53 Participants Participants will receive propranolol and topiramate.	Topiramate Plus Placebo n=44 Participants Participants will receive placebo and topiramate.	Topiramate Plus Propranolol, Prior, Stable Topiramate Participants with prior stable topiramate use received propranolol and topiramate.	Topiramate Plus Placebo, Prior, Stable Topiramate Participants with prior stable topiramate use received a placebo and topiramate.
Change From Baseline in Beck's Depression Inventory FastScreen Score at 6 Months	0.3 units on a scale Standard Deviation 0.25	0.6 units on a scale Standard Deviation 0.30	—	—

SECONDARY outcome

Timeframe: Baseline and 6 months

Population: per protocol

MIDAS scoring ranges from 0 to 270. The scores are divided into ranges of disability with higher scores indicating increased disability as follows: 0-5 (Grade I - Minimal or infrequent disability); 6-10 (Grade II - Mild or infrequent disability); 11-20 (Grade III - Moderate disability); and 21+ (Grade IV - Severe disability).

Outcome measures

Outcome measures
Measure	Topiramate Plus Propranolol n=53 Participants Participants will receive propranolol and topiramate.	Topiramate Plus Placebo n=44 Participants Participants will receive placebo and topiramate.	Topiramate Plus Propranolol, Prior, Stable Topiramate Participants with prior stable topiramate use received propranolol and topiramate.	Topiramate Plus Placebo, Prior, Stable Topiramate Participants with prior stable topiramate use received a placebo and topiramate.
Change From Baseline in Migraine Disability Assessment (MIDAS) Score at 6 Months	-3.18 units on a scale Standard Deviation 3.70	-3.46 units on a scale Standard Deviation 3.82	—	—

SECONDARY outcome

Timeframe: baseline and 6 months post randomization

Population: per protocol

The MSQ (version 2.1 copyrighted 1992, 1996, 1998 by Glaxo Wellcome Inc., Research Triangle Park, North Carolina) is a 14 item questionnaire. Item responses are summed and scored as a total score and three domains: Role Preventive, Role Restrictive, Emotional Function. Scores within each domain are rescaled to range from 0 to 100. A lower score indicates a poorer quality of life associated with that domain or in total. Because of the observed interaction within a domain, only domain scores were used as outcome measures for this study.

Outcome measures

Outcome measures
Measure	Topiramate Plus Propranolol n=53 Participants Participants will receive propranolol and topiramate.	Topiramate Plus Placebo n=62 Participants Participants will receive placebo and topiramate.	Topiramate Plus Propranolol, Prior, Stable Topiramate Participants with prior stable topiramate use received propranolol and topiramate.	Topiramate Plus Placebo, Prior, Stable Topiramate Participants with prior stable topiramate use received a placebo and topiramate.
Change From Baseline in Migraine Specific Quality of Life (MSQ)-Role Restrictive Score at 6 Months	-0.7 units on a scale Standard Deviation 5.5	-2.2 units on a scale Standard Deviation 5.71	—	—

SECONDARY outcome

Timeframe: Baseline and 6 months

Outcome measures

Outcome measures
Measure	Topiramate Plus Propranolol n=40 Participants Participants will receive propranolol and topiramate.	Topiramate Plus Placebo n=31 Participants Participants will receive placebo and topiramate.	Topiramate Plus Propranolol, Prior, Stable Topiramate n=13 Participants Participants with prior stable topiramate use received propranolol and topiramate.	Topiramate Plus Placebo, Prior, Stable Topiramate n=13 Participants Participants with prior stable topiramate use received a placebo and topiramate.
Change From Baseline in Migraine-Specific Quality of Life (MSQ)-Role Preventive at 6 Months	12.9 units on a scale Standard Deviation 2.88	5.9 units on a scale Standard Deviation 3.10	-11.5 units on a scale Standard Deviation 5.00	11.0 units on a scale Standard Deviation 5.06

SECONDARY outcome

Timeframe: Baseline and 6 Months

Outcome measures

Outcome measures
Measure	Topiramate Plus Propranolol n=53 Participants Participants will receive propranolol and topiramate.	Topiramate Plus Placebo n=62 Participants Participants will receive placebo and topiramate.	Topiramate Plus Propranolol, Prior, Stable Topiramate Participants with prior stable topiramate use received propranolol and topiramate.	Topiramate Plus Placebo, Prior, Stable Topiramate Participants with prior stable topiramate use received a placebo and topiramate.
Change From Baseline in Migraine-Specific Quality of Life (MSQ) - Emotional Function at 6 Months	8.9 units on a scale Standard Deviation 3.43	9.8 units on a scale Standard Deviation 3.80	—	—

Adverse Events

Topiramate Plus Placebo

Serious events: 5 serious events

Other events: 50 other events

Deaths: 0 deaths

Topiramate Plus Propranolol

Serious events: 7 serious events

Other events: 59 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Topiramate Plus Placebo n=95 participants at risk Participants will receive a placebo and topiramate.	Topiramate Plus Propranolol n=96 participants at risk Participants will receive propranolol and topiramate.
Nervous system disorders Dizziness	3.2% 3/95 • 6 months Self report and systematic questions at scheduled visits(Tingling or prickling;Nausea/Vomiting;Weight loss;Weight gain;More than usual fatigue;Depression;Trouble thinking;New or unusual problems with memory;Racing, pounding or skipping of heart(more than 1 time);Dizziness(more than 1 time);Impotence).	13.5% 13/96 • 6 months Self report and systematic questions at scheduled visits(Tingling or prickling;Nausea/Vomiting;Weight loss;Weight gain;More than usual fatigue;Depression;Trouble thinking;New or unusual problems with memory;Racing, pounding or skipping of heart(more than 1 time);Dizziness(more than 1 time);Impotence).
Nervous system disorders Memory Impairment	8.4% 8/95 • 6 months Self report and systematic questions at scheduled visits(Tingling or prickling;Nausea/Vomiting;Weight loss;Weight gain;More than usual fatigue;Depression;Trouble thinking;New or unusual problems with memory;Racing, pounding or skipping of heart(more than 1 time);Dizziness(more than 1 time);Impotence).	6.2% 6/96 • 6 months Self report and systematic questions at scheduled visits(Tingling or prickling;Nausea/Vomiting;Weight loss;Weight gain;More than usual fatigue;Depression;Trouble thinking;New or unusual problems with memory;Racing, pounding or skipping of heart(more than 1 time);Dizziness(more than 1 time);Impotence).
Nervous system disorders Mental Impairment	7.4% 7/95 • 6 months Self report and systematic questions at scheduled visits(Tingling or prickling;Nausea/Vomiting;Weight loss;Weight gain;More than usual fatigue;Depression;Trouble thinking;New or unusual problems with memory;Racing, pounding or skipping of heart(more than 1 time);Dizziness(more than 1 time);Impotence).	12.5% 12/96 • 6 months Self report and systematic questions at scheduled visits(Tingling or prickling;Nausea/Vomiting;Weight loss;Weight gain;More than usual fatigue;Depression;Trouble thinking;New or unusual problems with memory;Racing, pounding or skipping of heart(more than 1 time);Dizziness(more than 1 time);Impotence).
Nervous system disorders Paraesthesia	10.5% 10/95 • 6 months Self report and systematic questions at scheduled visits(Tingling or prickling;Nausea/Vomiting;Weight loss;Weight gain;More than usual fatigue;Depression;Trouble thinking;New or unusual problems with memory;Racing, pounding or skipping of heart(more than 1 time);Dizziness(more than 1 time);Impotence).	12.5% 12/96 • 6 months Self report and systematic questions at scheduled visits(Tingling or prickling;Nausea/Vomiting;Weight loss;Weight gain;More than usual fatigue;Depression;Trouble thinking;New or unusual problems with memory;Racing, pounding or skipping of heart(more than 1 time);Dizziness(more than 1 time);Impotence).
Psychiatric disorders Depression	3.2% 3/95 • 6 months Self report and systematic questions at scheduled visits(Tingling or prickling;Nausea/Vomiting;Weight loss;Weight gain;More than usual fatigue;Depression;Trouble thinking;New or unusual problems with memory;Racing, pounding or skipping of heart(more than 1 time);Dizziness(more than 1 time);Impotence).	8.3% 8/96 • 6 months Self report and systematic questions at scheduled visits(Tingling or prickling;Nausea/Vomiting;Weight loss;Weight gain;More than usual fatigue;Depression;Trouble thinking;New or unusual problems with memory;Racing, pounding or skipping of heart(more than 1 time);Dizziness(more than 1 time);Impotence).
Psychiatric disorders Insomnia	7.4% 7/95 • 6 months Self report and systematic questions at scheduled visits(Tingling or prickling;Nausea/Vomiting;Weight loss;Weight gain;More than usual fatigue;Depression;Trouble thinking;New or unusual problems with memory;Racing, pounding or skipping of heart(more than 1 time);Dizziness(more than 1 time);Impotence).	2.1% 2/96 • 6 months Self report and systematic questions at scheduled visits(Tingling or prickling;Nausea/Vomiting;Weight loss;Weight gain;More than usual fatigue;Depression;Trouble thinking;New or unusual problems with memory;Racing, pounding or skipping of heart(more than 1 time);Dizziness(more than 1 time);Impotence).
General disorders Fatigue	11.6% 11/95 • 6 months Self report and systematic questions at scheduled visits(Tingling or prickling;Nausea/Vomiting;Weight loss;Weight gain;More than usual fatigue;Depression;Trouble thinking;New or unusual problems with memory;Racing, pounding or skipping of heart(more than 1 time);Dizziness(more than 1 time);Impotence).	22.9% 22/96 • 6 months Self report and systematic questions at scheduled visits(Tingling or prickling;Nausea/Vomiting;Weight loss;Weight gain;More than usual fatigue;Depression;Trouble thinking;New or unusual problems with memory;Racing, pounding or skipping of heart(more than 1 time);Dizziness(more than 1 time);Impotence).
Vascular disorders Any Vascular Disorder	3.2% 3/95 • 6 months Self report and systematic questions at scheduled visits(Tingling or prickling;Nausea/Vomiting;Weight loss;Weight gain;More than usual fatigue;Depression;Trouble thinking;New or unusual problems with memory;Racing, pounding or skipping of heart(more than 1 time);Dizziness(more than 1 time);Impotence).	5.2% 5/96 • 6 months Self report and systematic questions at scheduled visits(Tingling or prickling;Nausea/Vomiting;Weight loss;Weight gain;More than usual fatigue;Depression;Trouble thinking;New or unusual problems with memory;Racing, pounding or skipping of heart(more than 1 time);Dizziness(more than 1 time);Impotence).

Additional Information

Anne S Lindblad, PhD

The EMMES Corporation

Phone: 301 251 1161

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60

Measure	Topiramate Plus Placebo n=95 participants at risk Participants will receive a placebo and topiramate.	Topiramate Plus Propranolol n=96 participants at risk Participants will receive propranolol and topiramate.
Psychiatric disorders Depression	0.00% 0/95 • 6 months Self report and systematic questions at scheduled visits(Tingling or prickling;Nausea/Vomiting;Weight loss;Weight gain;More than usual fatigue;Depression;Trouble thinking;New or unusual problems with memory;Racing, pounding or skipping of heart(more than 1 time);Dizziness(more than 1 time);Impotence).	1.0% 1/96 • Number of events 2 • 6 months Self report and systematic questions at scheduled visits(Tingling or prickling;Nausea/Vomiting;Weight loss;Weight gain;More than usual fatigue;Depression;Trouble thinking;New or unusual problems with memory;Racing, pounding or skipping of heart(more than 1 time);Dizziness(more than 1 time);Impotence).
Metabolism and nutrition disorders Dehydration	0.00% 0/95 • 6 months Self report and systematic questions at scheduled visits(Tingling or prickling;Nausea/Vomiting;Weight loss;Weight gain;More than usual fatigue;Depression;Trouble thinking;New or unusual problems with memory;Racing, pounding or skipping of heart(more than 1 time);Dizziness(more than 1 time);Impotence).	1.0% 1/96 • Number of events 1 • 6 months Self report and systematic questions at scheduled visits(Tingling or prickling;Nausea/Vomiting;Weight loss;Weight gain;More than usual fatigue;Depression;Trouble thinking;New or unusual problems with memory;Racing, pounding or skipping of heart(more than 1 time);Dizziness(more than 1 time);Impotence).
Psychiatric disorders Insomnia	0.00% 0/95 • 6 months Self report and systematic questions at scheduled visits(Tingling or prickling;Nausea/Vomiting;Weight loss;Weight gain;More than usual fatigue;Depression;Trouble thinking;New or unusual problems with memory;Racing, pounding or skipping of heart(more than 1 time);Dizziness(more than 1 time);Impotence).	1.0% 1/96 • Number of events 1 • 6 months Self report and systematic questions at scheduled visits(Tingling or prickling;Nausea/Vomiting;Weight loss;Weight gain;More than usual fatigue;Depression;Trouble thinking;New or unusual problems with memory;Racing, pounding or skipping of heart(more than 1 time);Dizziness(more than 1 time);Impotence).
Injury, poisoning and procedural complications Overdose	0.00% 0/95 • 6 months Self report and systematic questions at scheduled visits(Tingling or prickling;Nausea/Vomiting;Weight loss;Weight gain;More than usual fatigue;Depression;Trouble thinking;New or unusual problems with memory;Racing, pounding or skipping of heart(more than 1 time);Dizziness(more than 1 time);Impotence).	1.0% 1/96 • Number of events 1 • 6 months Self report and systematic questions at scheduled visits(Tingling or prickling;Nausea/Vomiting;Weight loss;Weight gain;More than usual fatigue;Depression;Trouble thinking;New or unusual problems with memory;Racing, pounding or skipping of heart(more than 1 time);Dizziness(more than 1 time);Impotence).
Nervous system disorders Paraesthesia	0.00% 0/95 • 6 months Self report and systematic questions at scheduled visits(Tingling or prickling;Nausea/Vomiting;Weight loss;Weight gain;More than usual fatigue;Depression;Trouble thinking;New or unusual problems with memory;Racing, pounding or skipping of heart(more than 1 time);Dizziness(more than 1 time);Impotence).	1.0% 1/96 • Number of events 1 • 6 months Self report and systematic questions at scheduled visits(Tingling or prickling;Nausea/Vomiting;Weight loss;Weight gain;More than usual fatigue;Depression;Trouble thinking;New or unusual problems with memory;Racing, pounding or skipping of heart(more than 1 time);Dizziness(more than 1 time);Impotence).
Gastrointestinal disorders Upper Abdominal Pain	0.00% 0/95 • 6 months Self report and systematic questions at scheduled visits(Tingling or prickling;Nausea/Vomiting;Weight loss;Weight gain;More than usual fatigue;Depression;Trouble thinking;New or unusual problems with memory;Racing, pounding or skipping of heart(more than 1 time);Dizziness(more than 1 time);Impotence).	1.0% 1/96 • Number of events 1 • 6 months Self report and systematic questions at scheduled visits(Tingling or prickling;Nausea/Vomiting;Weight loss;Weight gain;More than usual fatigue;Depression;Trouble thinking;New or unusual problems with memory;Racing, pounding or skipping of heart(more than 1 time);Dizziness(more than 1 time);Impotence).
Reproductive system and breast disorders Breast Pain	1.1% 1/95 • Number of events 1 • 6 months Self report and systematic questions at scheduled visits(Tingling or prickling;Nausea/Vomiting;Weight loss;Weight gain;More than usual fatigue;Depression;Trouble thinking;New or unusual problems with memory;Racing, pounding or skipping of heart(more than 1 time);Dizziness(more than 1 time);Impotence).	0.00% 0/96 • 6 months Self report and systematic questions at scheduled visits(Tingling or prickling;Nausea/Vomiting;Weight loss;Weight gain;More than usual fatigue;Depression;Trouble thinking;New or unusual problems with memory;Racing, pounding or skipping of heart(more than 1 time);Dizziness(more than 1 time);Impotence).
Reproductive system and breast disorders Breast Mass	1.1% 1/95 • Number of events 1 • 6 months Self report and systematic questions at scheduled visits(Tingling or prickling;Nausea/Vomiting;Weight loss;Weight gain;More than usual fatigue;Depression;Trouble thinking;New or unusual problems with memory;Racing, pounding or skipping of heart(more than 1 time);Dizziness(more than 1 time);Impotence).	0.00% 0/96 • 6 months Self report and systematic questions at scheduled visits(Tingling or prickling;Nausea/Vomiting;Weight loss;Weight gain;More than usual fatigue;Depression;Trouble thinking;New or unusual problems with memory;Racing, pounding or skipping of heart(more than 1 time);Dizziness(more than 1 time);Impotence).
Gastrointestinal disorders Vomiting	1.1% 1/95 • Number of events 1 • 6 months Self report and systematic questions at scheduled visits(Tingling or prickling;Nausea/Vomiting;Weight loss;Weight gain;More than usual fatigue;Depression;Trouble thinking;New or unusual problems with memory;Racing, pounding or skipping of heart(more than 1 time);Dizziness(more than 1 time);Impotence).	0.00% 0/96 • 6 months Self report and systematic questions at scheduled visits(Tingling or prickling;Nausea/Vomiting;Weight loss;Weight gain;More than usual fatigue;Depression;Trouble thinking;New or unusual problems with memory;Racing, pounding or skipping of heart(more than 1 time);Dizziness(more than 1 time);Impotence).
Respiratory, thoracic and mediastinal disorders Respiratory Tract Congestion	0.00% 0/95 • 6 months Self report and systematic questions at scheduled visits(Tingling or prickling;Nausea/Vomiting;Weight loss;Weight gain;More than usual fatigue;Depression;Trouble thinking;New or unusual problems with memory;Racing, pounding or skipping of heart(more than 1 time);Dizziness(more than 1 time);Impotence).	1.0% 1/96 • Number of events 1 • 6 months Self report and systematic questions at scheduled visits(Tingling or prickling;Nausea/Vomiting;Weight loss;Weight gain;More than usual fatigue;Depression;Trouble thinking;New or unusual problems with memory;Racing, pounding or skipping of heart(more than 1 time);Dizziness(more than 1 time);Impotence).
Nervous system disorders Headache	0.00% 0/95 • 6 months Self report and systematic questions at scheduled visits(Tingling or prickling;Nausea/Vomiting;Weight loss;Weight gain;More than usual fatigue;Depression;Trouble thinking;New or unusual problems with memory;Racing, pounding or skipping of heart(more than 1 time);Dizziness(more than 1 time);Impotence).	1.0% 1/96 • Number of events 1 • 6 months Self report and systematic questions at scheduled visits(Tingling or prickling;Nausea/Vomiting;Weight loss;Weight gain;More than usual fatigue;Depression;Trouble thinking;New or unusual problems with memory;Racing, pounding or skipping of heart(more than 1 time);Dizziness(more than 1 time);Impotence).
Pregnancy, puerperium and perinatal conditions Pregnancy	2.1% 2/95 • Number of events 2 • 6 months Self report and systematic questions at scheduled visits(Tingling or prickling;Nausea/Vomiting;Weight loss;Weight gain;More than usual fatigue;Depression;Trouble thinking;New or unusual problems with memory;Racing, pounding or skipping of heart(more than 1 time);Dizziness(more than 1 time);Impotence).	0.00% 0/96 • 6 months Self report and systematic questions at scheduled visits(Tingling or prickling;Nausea/Vomiting;Weight loss;Weight gain;More than usual fatigue;Depression;Trouble thinking;New or unusual problems with memory;Racing, pounding or skipping of heart(more than 1 time);Dizziness(more than 1 time);Impotence).
Reproductive system and breast disorders Pelvic Pain	1.1% 1/95 • Number of events 1 • 6 months Self report and systematic questions at scheduled visits(Tingling or prickling;Nausea/Vomiting;Weight loss;Weight gain;More than usual fatigue;Depression;Trouble thinking;New or unusual problems with memory;Racing, pounding or skipping of heart(more than 1 time);Dizziness(more than 1 time);Impotence).	0.00% 0/96 • 6 months Self report and systematic questions at scheduled visits(Tingling or prickling;Nausea/Vomiting;Weight loss;Weight gain;More than usual fatigue;Depression;Trouble thinking;New or unusual problems with memory;Racing, pounding or skipping of heart(more than 1 time);Dizziness(more than 1 time);Impotence).
Surgical and medical procedures Colporrhaphy	1.1% 1/95 • Number of events 1 • 6 months Self report and systematic questions at scheduled visits(Tingling or prickling;Nausea/Vomiting;Weight loss;Weight gain;More than usual fatigue;Depression;Trouble thinking;New or unusual problems with memory;Racing, pounding or skipping of heart(more than 1 time);Dizziness(more than 1 time);Impotence).	0.00% 0/96 • 6 months Self report and systematic questions at scheduled visits(Tingling or prickling;Nausea/Vomiting;Weight loss;Weight gain;More than usual fatigue;Depression;Trouble thinking;New or unusual problems with memory;Racing, pounding or skipping of heart(more than 1 time);Dizziness(more than 1 time);Impotence).
Nervous system disorders Syncope	0.00% 0/95 • 6 months Self report and systematic questions at scheduled visits(Tingling or prickling;Nausea/Vomiting;Weight loss;Weight gain;More than usual fatigue;Depression;Trouble thinking;New or unusual problems with memory;Racing, pounding or skipping of heart(more than 1 time);Dizziness(more than 1 time);Impotence).	1.0% 1/96 • Number of events 1 • 6 months Self report and systematic questions at scheduled visits(Tingling or prickling;Nausea/Vomiting;Weight loss;Weight gain;More than usual fatigue;Depression;Trouble thinking;New or unusual problems with memory;Racing, pounding or skipping of heart(more than 1 time);Dizziness(more than 1 time);Impotence).