Trial Outcomes & Findings for Sarizotan in Participants With Parkinson's Disease Suffering From Treatment Associated Dyskinesia (NCT NCT00105521)

Last Updated: 2018-04-02

Results Overview

On-time without dyskinesia was defined as a period (in hours) when the participant had no symptoms of off-time and was not asleep; also, participant had no difficulty in performing voluntary movements (that is, without dyskinesia). Off-time was defined as a period (in hours) when participant experienced increased parkinsonian symptoms (e.g. immobility or inability to move with ease). On-time was recorded by participant in a participant diary.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

398 participants

Primary outcome timeframe

Baseline, Week 12

Results posted on

2018-04-02

Participant Flow

Participant milestones

Participant milestones
Measure	Placebo Participants received placebo matched to sarizotan tablet orally twice daily up to Week 12.	Sarizotan 2 mg/Day Participants received sarizotan 2 milligrams per day (mg/day) (given in 2 divided daily doses) up to Week 12.	Sarizotan 4 mg/Day Participants received sarizotan 4 mg/day (given in 2 divided daily doses) up to Week 12.	Sarizotan 10 mg/Day Participants received sarizotan 10 mg/day (given in 2 divided daily doses) up to Week 12.
Overall Study STARTED	98	101	97	102
Overall Study COMPLETED	83	90	80	85
Overall Study NOT COMPLETED	15	11	17	17

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Participants received placebo matched to sarizotan tablet orally twice daily up to Week 12.	Sarizotan 2 mg/Day Participants received sarizotan 2 milligrams per day (mg/day) (given in 2 divided daily doses) up to Week 12.	Sarizotan 4 mg/Day Participants received sarizotan 4 mg/day (given in 2 divided daily doses) up to Week 12.	Sarizotan 10 mg/Day Participants received sarizotan 10 mg/day (given in 2 divided daily doses) up to Week 12.
Overall Study Other	1	1	2	0
Overall Study Adverse Event	10	4	10	8
Overall Study Withdrawal by Subject	1	0	1	4
Overall Study Lack of Efficacy	0	0	0	1
Overall Study Protocol Violation	3	5	4	4
Overall Study Lost to Follow-up	0	1	0	0

Baseline Characteristics

Sarizotan in Participants With Parkinson's Disease Suffering From Treatment Associated Dyskinesia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=98 Participants Participants received placebo matched to sarizotan tablet orally twice daily up to Week 12.	Sarizotan 2 mg/Day n=101 Participants Participants received sarizotan 2 mg/day (given in 2 divided daily doses) up to Week 12.	Sarizotan 4 mg/Day n=97 Participants Participants received sarizotan 4 mg/day (given in 2 divided daily doses) up to Week 12.	Sarizotan 10 mg/Day n=102 Participants Participants received sarizotan 10 mg/day (given in 2 divided daily doses) up to Week 12.	Total n=398 Participants Total of all reporting groups
Age, Continuous	63.1 years STANDARD_DEVIATION 8.3 • n=5 Participants	63.4 years STANDARD_DEVIATION 9.2 • n=7 Participants	63.2 years STANDARD_DEVIATION 9.7 • n=5 Participants	62.9 years STANDARD_DEVIATION 8.7 • n=4 Participants	63.2 years STANDARD_DEVIATION 9.0 • n=21 Participants
Sex: Female, Male Female	48 Participants n=5 Participants	47 Participants n=7 Participants	37 Participants n=5 Participants	45 Participants n=4 Participants	177 Participants n=21 Participants
Sex: Female, Male Male	50 Participants n=5 Participants	54 Participants n=7 Participants	60 Participants n=5 Participants	57 Participants n=4 Participants	221 Participants n=21 Participants

PRIMARY outcome

Timeframe: Baseline, Week 12

Population: Modified intent-to-treat (ITT) population included all randomized participants who received at least one treatment dose and who had at least one follow-up visit assessment for an efficacy target outcome.

Outcome measures

Outcome measures
Measure	Placebo n=95 Participants Participants received placebo matched to sarizotan tablet orally twice daily up to Week 12.	Sarizotan 2 mg/Day n=96 Participants Participants received sarizotan 2 mg/day (given in 2 divided daily doses) up to Week 12.	Sarizotan 4 mg/Day n=93 Participants Participants received sarizotan 4 mg/day (given in 2 divided daily doses) up to Week 12.	Sarizotan 10 mg/Day n=97 Participants Participants received sarizotan 10 mg/day (given in 2 divided daily doses) up to Week 12.
Change From Baseline in Diary-Based On-Time Without Dyskinesia at Week 12	1.6 hours/day Standard Deviation 3.3	1.9 hours/day Standard Deviation 3.8	1.7 hours/day Standard Deviation 3.0	1.8 hours/day Standard Deviation 3.1

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: Modified ITT population.

Modified AIMS was a 7-item investigator-assessed scale to assess severity of dyskinesia. Each item was rated on a 0 (none) to 4 (severe) scale. Modified AIMS score was sum of the all item scores and ranged from 0 to 28, where higher score indicated increased severity. Modified AIMS score in resting state as well as with activity is reported.

Outcome measures

Outcome measures
Measure	Placebo n=95 Participants Participants received placebo matched to sarizotan tablet orally twice daily up to Week 12.	Sarizotan 2 mg/Day n=96 Participants Participants received sarizotan 2 mg/day (given in 2 divided daily doses) up to Week 12.	Sarizotan 4 mg/Day n=93 Participants Participants received sarizotan 4 mg/day (given in 2 divided daily doses) up to Week 12.	Sarizotan 10 mg/Day n=97 Participants Participants received sarizotan 10 mg/day (given in 2 divided daily doses) up to Week 12.
Change From Baseline in Modified Abnormal Involuntary Movement Scale (AIMS) Score at Week 12 Change at Week 12: Modified AIMS at Rest	-2.7 units on a scale Standard Deviation 5.7	-3.0 units on a scale Standard Deviation 5.3	-2.7 units on a scale Standard Deviation 4.1	-3.7 units on a scale Standard Deviation 5.5
Change From Baseline in Modified Abnormal Involuntary Movement Scale (AIMS) Score at Week 12 Change at Week 12: Modified AIMS with Activity	-3.0 units on a scale Standard Deviation 5.9	-3.3 units on a scale Standard Deviation 5.6	-3.0 units on a scale Standard Deviation 4.8	-3.6 units on a scale Standard Deviation 6.0

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: Modified ITT population.

The UPDRS was an investigator-assessed rating tool to follow the longitudinal course of Parkinson's disease. Items 32 and 33 assessed duration of dyskinesia and disability due to dyskinesia, respectively. Both items were rated on a 0 to 4-point scale, where higher scores indicated higher duration of dyskinesia and more disability due to dyskinesia, respectively. The Items 32 and 33 composite score was sum of the individual item scores and ranged from 0 to 8, where higher score indicated more complications due to dyskinesia.

Outcome measures

Outcome measures
Measure	Placebo n=95 Participants Participants received placebo matched to sarizotan tablet orally twice daily up to Week 12.	Sarizotan 2 mg/Day n=96 Participants Participants received sarizotan 2 mg/day (given in 2 divided daily doses) up to Week 12.	Sarizotan 4 mg/Day n=93 Participants Participants received sarizotan 4 mg/day (given in 2 divided daily doses) up to Week 12.	Sarizotan 10 mg/Day n=97 Participants Participants received sarizotan 10 mg/day (given in 2 divided daily doses) up to Week 12.
Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Items 32 and 33 Composite Score at Week 12	-1.0 units on a scale Standard Deviation 1.4	-1.4 units on a scale Standard Deviation 1.6	-1.1 units on a scale Standard Deviation 1.4	-1.3 units on a scale Standard Deviation 1.3

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: modified ITT population.

The UPDRS was an investigator-assessed rating tool to follow the longitudinal course of Parkinson's disease. UPDRS Part III total score was the sum of the 27 answers (rated on 0 to 4-point scale) related to motor examination, and ranged from 0-108. Higher scores indicated worse motor function. Change from baseline in UPDRS Part III total score, assessed during on-time (time when the participant has no parkinsonian symptoms) as well as off-time (time when the patient experiences increased parkinsonian symptoms), is reported.

Outcome measures

Outcome measures
Measure	Placebo n=95 Participants Participants received placebo matched to sarizotan tablet orally twice daily up to Week 12.	Sarizotan 2 mg/Day n=96 Participants Participants received sarizotan 2 mg/day (given in 2 divided daily doses) up to Week 12.	Sarizotan 4 mg/Day n=93 Participants Participants received sarizotan 4 mg/day (given in 2 divided daily doses) up to Week 12.	Sarizotan 10 mg/Day n=97 Participants Participants received sarizotan 10 mg/day (given in 2 divided daily doses) up to Week 12.
Change From Baseline in UPDRS Part III Total Score at Week 12 Change at Week 12: UPDRS Part III On-Time	0.3 units on a scale Standard Deviation 6.8	-0.1 units on a scale Standard Deviation 6.4	-0.1 units on a scale Standard Deviation 6.8	-0.8 units on a scale Standard Deviation 7.1
Change From Baseline in UPDRS Part III Total Score at Week 12 Change at Week 12: UPDRS Part III Off-Time	-3.0 units on a scale Standard Deviation 8.7	-1.1 units on a scale Standard Deviation 8.7	-0.0 units on a scale Standard Deviation 7.6	-1.8 units on a scale Standard Deviation 9.0

Adverse Events

Placebo

Serious events: 5 serious events

Other events: 81 other events

Deaths: 0 deaths

Sarizotan 2 mg/Day

Serious events: 8 serious events

Other events: 78 other events

Deaths: 0 deaths

Sarizotan 4 mg/Day

Serious events: 7 serious events

Other events: 75 other events

Deaths: 0 deaths

Sarizotan 10 mg/Day

Serious events: 2 serious events

Other events: 85 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo n=98 participants at risk Participants received placebo matched to sarizotan tablet orally twice daily up to Week 12.	Sarizotan 2 mg/Day n=101 participants at risk Participants received sarizotan 2 mg/day (given in 2 divided daily doses) up to Week 12.	Sarizotan 4 mg/Day n=97 participants at risk Participants received sarizotan 4 mg/day (given in 2 divided daily doses) up to Week 12.	Sarizotan 10 mg/Day n=102 participants at risk Participants received sarizotan 10 mg/day (given in 2 divided daily doses) up to Week 12.
General disorders	5.1% 5/98 Among serious adverse events (SAEs), only data for total # affected by any SAE is available. Due diligence was done and all potential information sources have been exhausted; no further information could be retrieved. Hence, for SAEs the preferred term is reported as "Not Available" and System Organ Class as "General Disorders".	7.9% 8/101 Among serious adverse events (SAEs), only data for total # affected by any SAE is available. Due diligence was done and all potential information sources have been exhausted; no further information could be retrieved. Hence, for SAEs the preferred term is reported as "Not Available" and System Organ Class as "General Disorders".	7.2% 7/97 Among serious adverse events (SAEs), only data for total # affected by any SAE is available. Due diligence was done and all potential information sources have been exhausted; no further information could be retrieved. Hence, for SAEs the preferred term is reported as "Not Available" and System Organ Class as "General Disorders".	2.0% 2/102 Among serious adverse events (SAEs), only data for total # affected by any SAE is available. Due diligence was done and all potential information sources have been exhausted; no further information could be retrieved. Hence, for SAEs the preferred term is reported as "Not Available" and System Organ Class as "General Disorders".

Other adverse events

Other adverse events
Measure	Placebo n=98 participants at risk Participants received placebo matched to sarizotan tablet orally twice daily up to Week 12.	Sarizotan 2 mg/Day n=101 participants at risk Participants received sarizotan 2 mg/day (given in 2 divided daily doses) up to Week 12.	Sarizotan 4 mg/Day n=97 participants at risk Participants received sarizotan 4 mg/day (given in 2 divided daily doses) up to Week 12.	Sarizotan 10 mg/Day n=102 participants at risk Participants received sarizotan 10 mg/day (given in 2 divided daily doses) up to Week 12.
Nervous system disorders Parkinsonism aggravated	27.6% 27/98 Among serious adverse events (SAEs), only data for total # affected by any SAE is available. Due diligence was done and all potential information sources have been exhausted; no further information could be retrieved. Hence, for SAEs the preferred term is reported as "Not Available" and System Organ Class as "General Disorders".	22.8% 23/101 Among serious adverse events (SAEs), only data for total # affected by any SAE is available. Due diligence was done and all potential information sources have been exhausted; no further information could be retrieved. Hence, for SAEs the preferred term is reported as "Not Available" and System Organ Class as "General Disorders".	36.1% 35/97 Among serious adverse events (SAEs), only data for total # affected by any SAE is available. Due diligence was done and all potential information sources have been exhausted; no further information could be retrieved. Hence, for SAEs the preferred term is reported as "Not Available" and System Organ Class as "General Disorders".	31.4% 32/102 Among serious adverse events (SAEs), only data for total # affected by any SAE is available. Due diligence was done and all potential information sources have been exhausted; no further information could be retrieved. Hence, for SAEs the preferred term is reported as "Not Available" and System Organ Class as "General Disorders".
Musculoskeletal and connective tissue disorders Dyskinesia aggravated	7.1% 7/98 Among serious adverse events (SAEs), only data for total # affected by any SAE is available. Due diligence was done and all potential information sources have been exhausted; no further information could be retrieved. Hence, for SAEs the preferred term is reported as "Not Available" and System Organ Class as "General Disorders".	10.9% 11/101 Among serious adverse events (SAEs), only data for total # affected by any SAE is available. Due diligence was done and all potential information sources have been exhausted; no further information could be retrieved. Hence, for SAEs the preferred term is reported as "Not Available" and System Organ Class as "General Disorders".	7.2% 7/97 Among serious adverse events (SAEs), only data for total # affected by any SAE is available. Due diligence was done and all potential information sources have been exhausted; no further information could be retrieved. Hence, for SAEs the preferred term is reported as "Not Available" and System Organ Class as "General Disorders".	9.8% 10/102 Among serious adverse events (SAEs), only data for total # affected by any SAE is available. Due diligence was done and all potential information sources have been exhausted; no further information could be retrieved. Hence, for SAEs the preferred term is reported as "Not Available" and System Organ Class as "General Disorders".
Gastrointestinal disorders Nausea	6.1% 6/98 Among serious adverse events (SAEs), only data for total # affected by any SAE is available. Due diligence was done and all potential information sources have been exhausted; no further information could be retrieved. Hence, for SAEs the preferred term is reported as "Not Available" and System Organ Class as "General Disorders".	5.9% 6/101 Among serious adverse events (SAEs), only data for total # affected by any SAE is available. Due diligence was done and all potential information sources have been exhausted; no further information could be retrieved. Hence, for SAEs the preferred term is reported as "Not Available" and System Organ Class as "General Disorders".	7.2% 7/97 Among serious adverse events (SAEs), only data for total # affected by any SAE is available. Due diligence was done and all potential information sources have been exhausted; no further information could be retrieved. Hence, for SAEs the preferred term is reported as "Not Available" and System Organ Class as "General Disorders".	12.7% 13/102 Among serious adverse events (SAEs), only data for total # affected by any SAE is available. Due diligence was done and all potential information sources have been exhausted; no further information could be retrieved. Hence, for SAEs the preferred term is reported as "Not Available" and System Organ Class as "General Disorders".
Injury, poisoning and procedural complications Falls	4.1% 4/98 Among serious adverse events (SAEs), only data for total # affected by any SAE is available. Due diligence was done and all potential information sources have been exhausted; no further information could be retrieved. Hence, for SAEs the preferred term is reported as "Not Available" and System Organ Class as "General Disorders".	10.9% 11/101 Among serious adverse events (SAEs), only data for total # affected by any SAE is available. Due diligence was done and all potential information sources have been exhausted; no further information could be retrieved. Hence, for SAEs the preferred term is reported as "Not Available" and System Organ Class as "General Disorders".	3.1% 3/97 Among serious adverse events (SAEs), only data for total # affected by any SAE is available. Due diligence was done and all potential information sources have been exhausted; no further information could be retrieved. Hence, for SAEs the preferred term is reported as "Not Available" and System Organ Class as "General Disorders".	2.0% 2/102 Among serious adverse events (SAEs), only data for total # affected by any SAE is available. Due diligence was done and all potential information sources have been exhausted; no further information could be retrieved. Hence, for SAEs the preferred term is reported as "Not Available" and System Organ Class as "General Disorders".
Musculoskeletal and connective tissue disorders Tremor aggravated	5.1% 5/98 Among serious adverse events (SAEs), only data for total # affected by any SAE is available. Due diligence was done and all potential information sources have been exhausted; no further information could be retrieved. Hence, for SAEs the preferred term is reported as "Not Available" and System Organ Class as "General Disorders".	6.9% 7/101 Among serious adverse events (SAEs), only data for total # affected by any SAE is available. Due diligence was done and all potential information sources have been exhausted; no further information could be retrieved. Hence, for SAEs the preferred term is reported as "Not Available" and System Organ Class as "General Disorders".	1.0% 1/97 Among serious adverse events (SAEs), only data for total # affected by any SAE is available. Due diligence was done and all potential information sources have been exhausted; no further information could be retrieved. Hence, for SAEs the preferred term is reported as "Not Available" and System Organ Class as "General Disorders".	5.9% 6/102 Among serious adverse events (SAEs), only data for total # affected by any SAE is available. Due diligence was done and all potential information sources have been exhausted; no further information could be retrieved. Hence, for SAEs the preferred term is reported as "Not Available" and System Organ Class as "General Disorders".
Nervous system disorders Somnolence	3.1% 3/98 Among serious adverse events (SAEs), only data for total # affected by any SAE is available. Due diligence was done and all potential information sources have been exhausted; no further information could be retrieved. Hence, for SAEs the preferred term is reported as "Not Available" and System Organ Class as "General Disorders".	5.0% 5/101 Among serious adverse events (SAEs), only data for total # affected by any SAE is available. Due diligence was done and all potential information sources have been exhausted; no further information could be retrieved. Hence, for SAEs the preferred term is reported as "Not Available" and System Organ Class as "General Disorders".	3.1% 3/97 Among serious adverse events (SAEs), only data for total # affected by any SAE is available. Due diligence was done and all potential information sources have been exhausted; no further information could be retrieved. Hence, for SAEs the preferred term is reported as "Not Available" and System Organ Class as "General Disorders".	5.9% 6/102 Among serious adverse events (SAEs), only data for total # affected by any SAE is available. Due diligence was done and all potential information sources have been exhausted; no further information could be retrieved. Hence, for SAEs the preferred term is reported as "Not Available" and System Organ Class as "General Disorders".
General disorders Fatigue	5.1% 5/98 Among serious adverse events (SAEs), only data for total # affected by any SAE is available. Due diligence was done and all potential information sources have been exhausted; no further information could be retrieved. Hence, for SAEs the preferred term is reported as "Not Available" and System Organ Class as "General Disorders".	5.9% 6/101 Among serious adverse events (SAEs), only data for total # affected by any SAE is available. Due diligence was done and all potential information sources have been exhausted; no further information could be retrieved. Hence, for SAEs the preferred term is reported as "Not Available" and System Organ Class as "General Disorders".	3.1% 3/97 Among serious adverse events (SAEs), only data for total # affected by any SAE is available. Due diligence was done and all potential information sources have been exhausted; no further information could be retrieved. Hence, for SAEs the preferred term is reported as "Not Available" and System Organ Class as "General Disorders".	2.0% 2/102 Among serious adverse events (SAEs), only data for total # affected by any SAE is available. Due diligence was done and all potential information sources have been exhausted; no further information could be retrieved. Hence, for SAEs the preferred term is reported as "Not Available" and System Organ Class as "General Disorders".
Nervous system disorders Headache	2.0% 2/98 Among serious adverse events (SAEs), only data for total # affected by any SAE is available. Due diligence was done and all potential information sources have been exhausted; no further information could be retrieved. Hence, for SAEs the preferred term is reported as "Not Available" and System Organ Class as "General Disorders".	5.0% 5/101 Among serious adverse events (SAEs), only data for total # affected by any SAE is available. Due diligence was done and all potential information sources have been exhausted; no further information could be retrieved. Hence, for SAEs the preferred term is reported as "Not Available" and System Organ Class as "General Disorders".	5.2% 5/97 Among serious adverse events (SAEs), only data for total # affected by any SAE is available. Due diligence was done and all potential information sources have been exhausted; no further information could be retrieved. Hence, for SAEs the preferred term is reported as "Not Available" and System Organ Class as "General Disorders".	2.0% 2/102 Among serious adverse events (SAEs), only data for total # affected by any SAE is available. Due diligence was done and all potential information sources have been exhausted; no further information could be retrieved. Hence, for SAEs the preferred term is reported as "Not Available" and System Organ Class as "General Disorders".
Musculoskeletal and connective tissue disorders Arthralgia	4.1% 4/98 Among serious adverse events (SAEs), only data for total # affected by any SAE is available. Due diligence was done and all potential information sources have been exhausted; no further information could be retrieved. Hence, for SAEs the preferred term is reported as "Not Available" and System Organ Class as "General Disorders".	0.99% 1/101 Among serious adverse events (SAEs), only data for total # affected by any SAE is available. Due diligence was done and all potential information sources have been exhausted; no further information could be retrieved. Hence, for SAEs the preferred term is reported as "Not Available" and System Organ Class as "General Disorders".	4.1% 4/97 Among serious adverse events (SAEs), only data for total # affected by any SAE is available. Due diligence was done and all potential information sources have been exhausted; no further information could be retrieved. Hence, for SAEs the preferred term is reported as "Not Available" and System Organ Class as "General Disorders".	4.9% 5/102 Among serious adverse events (SAEs), only data for total # affected by any SAE is available. Due diligence was done and all potential information sources have been exhausted; no further information could be retrieved. Hence, for SAEs the preferred term is reported as "Not Available" and System Organ Class as "General Disorders".
Investigations Blood creatine protein kinase increased	5.1% 5/98 Among serious adverse events (SAEs), only data for total # affected by any SAE is available. Due diligence was done and all potential information sources have been exhausted; no further information could be retrieved. Hence, for SAEs the preferred term is reported as "Not Available" and System Organ Class as "General Disorders".	0.99% 1/101 Among serious adverse events (SAEs), only data for total # affected by any SAE is available. Due diligence was done and all potential information sources have been exhausted; no further information could be retrieved. Hence, for SAEs the preferred term is reported as "Not Available" and System Organ Class as "General Disorders".	4.1% 4/97 Among serious adverse events (SAEs), only data for total # affected by any SAE is available. Due diligence was done and all potential information sources have been exhausted; no further information could be retrieved. Hence, for SAEs the preferred term is reported as "Not Available" and System Organ Class as "General Disorders".	2.9% 3/102 Among serious adverse events (SAEs), only data for total # affected by any SAE is available. Due diligence was done and all potential information sources have been exhausted; no further information could be retrieved. Hence, for SAEs the preferred term is reported as "Not Available" and System Organ Class as "General Disorders".
Respiratory, thoracic and mediastinal disorders Nasopharyngitis	8.2% 8/98 Among serious adverse events (SAEs), only data for total # affected by any SAE is available. Due diligence was done and all potential information sources have been exhausted; no further information could be retrieved. Hence, for SAEs the preferred term is reported as "Not Available" and System Organ Class as "General Disorders".	2.0% 2/101 Among serious adverse events (SAEs), only data for total # affected by any SAE is available. Due diligence was done and all potential information sources have been exhausted; no further information could be retrieved. Hence, for SAEs the preferred term is reported as "Not Available" and System Organ Class as "General Disorders".	1.0% 1/97 Among serious adverse events (SAEs), only data for total # affected by any SAE is available. Due diligence was done and all potential information sources have been exhausted; no further information could be retrieved. Hence, for SAEs the preferred term is reported as "Not Available" and System Organ Class as "General Disorders".	0.98% 1/102 Among serious adverse events (SAEs), only data for total # affected by any SAE is available. Due diligence was done and all potential information sources have been exhausted; no further information could be retrieved. Hence, for SAEs the preferred term is reported as "Not Available" and System Organ Class as "General Disorders".
Nervous system disorders Dizziness	5.1% 5/98 Among serious adverse events (SAEs), only data for total # affected by any SAE is available. Due diligence was done and all potential information sources have been exhausted; no further information could be retrieved. Hence, for SAEs the preferred term is reported as "Not Available" and System Organ Class as "General Disorders".	0.00% 0/101 Among serious adverse events (SAEs), only data for total # affected by any SAE is available. Due diligence was done and all potential information sources have been exhausted; no further information could be retrieved. Hence, for SAEs the preferred term is reported as "Not Available" and System Organ Class as "General Disorders".	2.1% 2/97 Among serious adverse events (SAEs), only data for total # affected by any SAE is available. Due diligence was done and all potential information sources have been exhausted; no further information could be retrieved. Hence, for SAEs the preferred term is reported as "Not Available" and System Organ Class as "General Disorders".	2.9% 3/102 Among serious adverse events (SAEs), only data for total # affected by any SAE is available. Due diligence was done and all potential information sources have been exhausted; no further information could be retrieved. Hence, for SAEs the preferred term is reported as "Not Available" and System Organ Class as "General Disorders".

Additional Information

Merck KGaA Communication Center,

Merck Serono, a division of Merck KGaA

Phone: 496151725200

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place