Trial Outcomes & Findings for Initial Treatment of Patients With Immune Thrombocytopenic Purpura (NCT NCT00991939)
NCT ID: NCT00991939
Last Updated: 2014-02-14
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
8 participants
Primary outcome timeframe
From 60 days through 365 days after study entry.
Results posted on
2014-02-14
Participant Flow
Participant milestones
| Measure |
High Dose Pulse Dexamethasone
Dexamethasone USP Micronized : The dose for dexamethasone is 30 mg/day for patients \< 60 kg and 40 mg/day for patients \> 60 kg. The patient will be dosed on days 1-4, 15-18 and 29-32. On the remaining days during the treatment phase of the study, the patient will receive placebo capsules.
|
Standard Prednisone Therapy
Prednisone : Prednisone will be administered to study patients at a dose of 60 mg/day for patients less than 60 kg and 80 mg/day for patients \> 60 kg for 21 days. The following schedule for tapering of prednisone will be used: after three weeks of treatment at either 60 mg/day (for patients \< 60 kg) or 80 mg/day (for patients ≥ 60 kg), the dose will be reduced to 40 mg/day for 1 week, then 20 mg/day for 1 week, then 10 mg/day for 1 week, then 5 mg/day for 1 week and then stopped. Placebo capsules will be added as necessary during the treatment phase of the study, to maintain blinding.
|
|---|---|---|
|
Overall Study
STARTED
|
5
|
3
|
|
Overall Study
COMPLETED
|
0
|
1
|
|
Overall Study
NOT COMPLETED
|
5
|
2
|
Reasons for withdrawal
| Measure |
High Dose Pulse Dexamethasone
Dexamethasone USP Micronized : The dose for dexamethasone is 30 mg/day for patients \< 60 kg and 40 mg/day for patients \> 60 kg. The patient will be dosed on days 1-4, 15-18 and 29-32. On the remaining days during the treatment phase of the study, the patient will receive placebo capsules.
|
Standard Prednisone Therapy
Prednisone : Prednisone will be administered to study patients at a dose of 60 mg/day for patients less than 60 kg and 80 mg/day for patients \> 60 kg for 21 days. The following schedule for tapering of prednisone will be used: after three weeks of treatment at either 60 mg/day (for patients \< 60 kg) or 80 mg/day (for patients ≥ 60 kg), the dose will be reduced to 40 mg/day for 1 week, then 20 mg/day for 1 week, then 10 mg/day for 1 week, then 5 mg/day for 1 week and then stopped. Placebo capsules will be added as necessary during the treatment phase of the study, to maintain blinding.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Entire study terminated
|
4
|
1
|
Baseline Characteristics
Initial Treatment of Patients With Immune Thrombocytopenic Purpura
Baseline characteristics by cohort
| Measure |
High Dose Pulse Dexamethasone
n=5 Participants
Dexamethasone USP Micronized : The dose for dexamethasone is 30 mg/day for patients \< 60 kg and 40 mg/day for patients \> 60 kg. The patient will be dosed on days 1-4, 15-18 and 29-32. On the remaining days during the treatment phase of the study, the patient will receive placebo capsules.
|
Standard Prednisone Therapy
n=3 Participants
Prednisone : Prednisone will be administered to study patients at a dose of 60 mg/day for patients less than 60 kg and 80 mg/day for patients \> 60 kg for 21 days. The following schedule for tapering of prednisone will be used: after three weeks of treatment at either 60 mg/day (for patients \< 60 kg) or 80 mg/day (for patients ≥ 60 kg), the dose will be reduced to 40 mg/day for 1 week, then 20 mg/day for 1 week, then 10 mg/day for 1 week, then 5 mg/day for 1 week and then stopped. Placebo capsules will be added as necessary during the treatment phase of the study, to maintain blinding.
|
Total
n=8 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
6 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
|
37.2 years
STANDARD_DEVIATION 15.6 • n=5 Participants
|
62.5 years
STANDARD_DEVIATION 35.8 • n=7 Participants
|
46.7 years
STANDARD_DEVIATION 26.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=5 Participants
|
3 participants
n=7 Participants
|
8 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From 60 days through 365 days after study entry.Outcome measures
| Measure |
High Dose Pulse Dexamethasone
n=3 Participants
Dexamethasone USP Micronized : The dose for dexamethasone is 30 mg/day for patients \< 60 kg and 40 mg/day for patients \> 60 kg. The patient will be dosed on days 1-4, 15-18 and 29-32. On the remaining days during the treatment phase of the study, the patient will receive placebo capsules.
|
Standard Prednisone Therapy
n=1 Participants
Prednisone : Prednisone will be administered to study patients at a dose of 60 mg/day for patients less than 60 kg and 80 mg/day for patients \> 60 kg for 21 days. The following schedule for tapering of prednisone will be used: after three weeks of treatment at either 60 mg/day (for patients \< 60 kg) or 80 mg/day (for patients ≥ 60 kg), the dose will be reduced to 40 mg/day for 1 week, then 20 mg/day for 1 week, then 10 mg/day for 1 week, then 5 mg/day for 1 week and then stopped. Placebo capsules will be added as necessary during the treatment phase of the study, to maintain blinding.
|
|---|---|---|
|
The Percentage of Patients in Each Treatment Arm Who Remain Free of All ITP Therapy With a Platelet Count ≥ 50,000/μl From 60 Days Through 365 Days After Study Entry.
|
0 percentage of subjects
|
0 percentage of subjects
|
SECONDARY outcome
Timeframe: From 60 days through 365 days after study entryPopulation: Due to the same sample size at the time that the study was terminated, this endpoint was not analyzed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 365 days after study entryPopulation: Due to the same sample size at the time that the study was terminated, this endpoint was not analyzed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From 180 days through 365 days after study entryPopulation: Due to the same sample size at the time that the study was terminated, this endpoint was not analyzed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From 180 days through 365 days after study entryPopulation: Due to the same sample size at the time that the study was terminated, this endpoint was not analyzed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Through 60 days after study entryPopulation: Due to the same sample size at the time that the study was terminated, this endpoint was not analyzed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From 60 days through 365 days after study entryPopulation: Due to the same sample size at the time that the study was terminated, this endpoint was not analyzed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From 60 days through 365 days after study entryPopulation: Due to the same sample size at the time that the study was terminated, this endpoint was not analyzed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From 60 days through 365 days after study entryPopulation: Due to the same sample size at the time that the study was terminated, this endpoint was not analyzed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Through 365 days after study entryPopulation: Due to the same sample size at the time that the study was terminated, this endpoint was not analyzed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Weeks 4, 8, and 52 after study entryPopulation: Due to the same sample size at the time that the study was terminated, this endpoint was not analyzed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Through 365 days after study entryPopulation: Due to the same sample size at the time that the study was terminated, this endpoint was not analyzed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 49 days after study entryPopulation: Due to the same sample size at the time that the study was terminated, this endpoint was not analyzed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Through 1 year after study entryPopulation: Due to the same sample size at the time that the study was terminated, this endpoint was not analyzed.
Outcome measures
Outcome data not reported
Adverse Events
High Dose Pulse Dexamethasone
Serious events: 3 serious events
Other events: 5 other events
Deaths: 0 deaths
Standard Prednisone Therapy
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
High Dose Pulse Dexamethasone
n=5 participants at risk
Dexamethasone USP Micronized: The dose for dexamethasone is 30 mg/day for patients \< 60 kg and 40 mg/day for patients \> 60 kg. The patient will be dosed on days 1-4, 15-18 and 29-32. On the remaining days during the treatment phase of the study, the patient will receive placebo capsules.
|
Standard Prednisone Therapy
n=3 participants at risk
Prednisone: Prednisone will be administered to study patients at a dose of 60 mg/day for patients less than 60 kg and 80 mg/day for patients \> 60 kg for 21 days. The following schedule for tapering of prednisone will be used: after three weeks of treatment at either 60 mg/day (for patients \< 60 kg) or 80 mg/day (for patients ≥ 60 kg), the dose will be reduced to 40 mg/day for 1 week, then 20 mg/day for 1 week, then 10 mg/day for 1 week, then 5 mg/day for 1 week and then stopped. Placebo capsules will be added as necessary during the treatment phase of the study, to maintain blinding.
|
|---|---|---|
|
General disorders
Adverse drug reaction
|
20.0%
1/5 • Number of events 1
|
0.00%
0/3
|
|
Gastrointestinal disorders
Gingival bleeding
|
20.0%
1/5 • Number of events 1
|
0.00%
0/3
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
20.0%
1/5 • Number of events 1
|
0.00%
0/3
|
|
Nervous system disorders
Headache
|
20.0%
1/5 • Number of events 1
|
0.00%
0/3
|
|
Skin and subcutaneous tissue disorders
Increased tendency to bruise
|
20.0%
1/5 • Number of events 1
|
0.00%
0/3
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/5
|
33.3%
1/3 • Number of events 1
|
|
Investigations
Occult blood
|
20.0%
1/5 • Number of events 1
|
0.00%
0/3
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
40.0%
2/5 • Number of events 2
|
0.00%
0/3
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.00%
0/5
|
33.3%
1/3 • Number of events 1
|
Other adverse events
| Measure |
High Dose Pulse Dexamethasone
n=5 participants at risk
Dexamethasone USP Micronized: The dose for dexamethasone is 30 mg/day for patients \< 60 kg and 40 mg/day for patients \> 60 kg. The patient will be dosed on days 1-4, 15-18 and 29-32. On the remaining days during the treatment phase of the study, the patient will receive placebo capsules.
|
Standard Prednisone Therapy
n=3 participants at risk
Prednisone: Prednisone will be administered to study patients at a dose of 60 mg/day for patients less than 60 kg and 80 mg/day for patients \> 60 kg for 21 days. The following schedule for tapering of prednisone will be used: after three weeks of treatment at either 60 mg/day (for patients \< 60 kg) or 80 mg/day (for patients ≥ 60 kg), the dose will be reduced to 40 mg/day for 1 week, then 20 mg/day for 1 week, then 10 mg/day for 1 week, then 5 mg/day for 1 week and then stopped. Placebo capsules will be added as necessary during the treatment phase of the study, to maintain blinding.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
20.0%
1/5 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
|
Metabolism and nutrition disorders
Abnormal weight gain
|
0.00%
0/5
|
33.3%
1/3 • Number of events 1
|
|
Psychiatric disorders
Agitation
|
20.0%
1/5 • Number of events 2
|
0.00%
0/3
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
20.0%
1/5 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
|
Blood and lymphatic system disorders
Anaemia vitamin B12 deficiency
|
20.0%
1/5 • Number of events 1
|
0.00%
0/3
|
|
Gastrointestinal disorders
Anal haemorrhage
|
0.00%
0/5
|
33.3%
1/3 • Number of events 1
|
|
Psychiatric disorders
Anxiety
|
100.0%
5/5 • Number of events 8
|
66.7%
2/3 • Number of events 2
|
|
Metabolism and nutrition disorders
Appetite disorder
|
20.0%
1/5 • Number of events 1
|
0.00%
0/3
|
|
General disorders
Application site bleeding
|
20.0%
1/5 • Number of events 1
|
0.00%
0/3
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
60.0%
3/5 • Number of events 4
|
100.0%
3/3 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
Blood blister
|
0.00%
0/5
|
66.7%
2/3 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/5
|
33.3%
1/3 • Number of events 2
|
|
Reproductive system and breast disorders
Breast enlargement
|
20.0%
1/5 • Number of events 1
|
0.00%
0/3
|
|
Infections and infestations
Bronchitis
|
20.0%
1/5 • Number of events 3
|
0.00%
0/3
|
|
General disorders
Chest pain
|
60.0%
3/5 • Number of events 4
|
33.3%
1/3 • Number of events 1
|
|
Eye disorders
Conjunctival haemorrhage
|
20.0%
1/5 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/5
|
33.3%
1/3 • Number of events 1
|
|
Endocrine disorders
Cushingoid
|
20.0%
1/5 • Number of events 1
|
33.3%
1/3 • Number of events 2
|
|
Metabolism and nutrition disorders
Dehydration
|
20.0%
1/5 • Number of events 2
|
0.00%
0/3
|
|
Psychiatric disorders
Depressed mood
|
20.0%
1/5 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
|
Psychiatric disorders
Depression
|
40.0%
2/5 • Number of events 2
|
33.3%
1/3 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
20.0%
1/5 • Number of events 1
|
0.00%
0/3
|
|
Gastrointestinal disorders
Diarrhoea
|
40.0%
2/5 • Number of events 2
|
0.00%
0/3
|
|
Nervous system disorders
Dizziness
|
20.0%
1/5 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
100.0%
5/5 • Number of events 6
|
66.7%
2/3 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
20.0%
1/5 • Number of events 1
|
0.00%
0/3
|
|
Ear and labyrinth disorders
Ear pain
|
20.0%
1/5 • Number of events 1
|
0.00%
0/3
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/5
|
33.3%
1/3 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
60.0%
3/5 • Number of events 4
|
66.7%
2/3 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Erythema
|
20.0%
1/5 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
|
Eye disorders
Eye pain
|
20.0%
1/5 • Number of events 1
|
0.00%
0/3
|
|
General disorders
Face oedema
|
20.0%
1/5 • Number of events 2
|
33.3%
1/3 • Number of events 2
|
|
General disorders
Fat tissue increased
|
20.0%
1/5 • Number of events 1
|
66.7%
2/3 • Number of events 2
|
|
General disorders
Fatigue
|
100.0%
5/5 • Number of events 8
|
100.0%
3/3 • Number of events 3
|
|
General disorders
Feeling jittery
|
20.0%
1/5 • Number of events 1
|
0.00%
0/3
|
|
Vascular disorders
Flushing
|
40.0%
2/5 • Number of events 2
|
66.7%
2/3 • Number of events 2
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.00%
0/5
|
33.3%
1/3 • Number of events 1
|
|
Renal and urinary disorders
Haematuria
|
20.0%
1/5 • Number of events 1
|
0.00%
0/3
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
20.0%
1/5 • Number of events 1
|
0.00%
0/3
|
|
Gastrointestinal disorders
Haemorrhoids
|
20.0%
1/5 • Number of events 1
|
0.00%
0/3
|
|
Nervous system disorders
Headache
|
40.0%
2/5 • Number of events 2
|
33.3%
1/3 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
80.0%
4/5 • Number of events 6
|
0.00%
0/3
|
|
Vascular disorders
Hypertension
|
0.00%
0/5
|
33.3%
1/3 • Number of events 1
|
|
Metabolism and nutrition disorders
Increased appetite
|
80.0%
4/5 • Number of events 7
|
100.0%
3/3 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Increased tendency to bruise
|
100.0%
5/5 • Number of events 10
|
66.7%
2/3 • Number of events 4
|
|
Infections and infestations
Influenza
|
20.0%
1/5 • Number of events 1
|
0.00%
0/3
|
|
Psychiatric disorders
Insomnia
|
60.0%
3/5 • Number of events 4
|
33.3%
1/3 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
20.0%
1/5 • Number of events 1
|
33.3%
1/3 • Number of events 4
|
|
Psychiatric disorders
Libido decreased
|
20.0%
1/5 • Number of events 1
|
0.00%
0/3
|
|
General disorders
Malaise
|
20.0%
1/5 • Number of events 1
|
0.00%
0/3
|
|
Reproductive system and breast disorders
Male sexual dysfunction
|
0.00%
0/5
|
66.7%
2/3 • Number of events 2
|
|
Reproductive system and breast disorders
Menorrhagia
|
20.0%
1/5 • Number of events 4
|
0.00%
0/3
|
|
Reproductive system and breast disorders
Menstruation irregular
|
20.0%
1/5 • Number of events 3
|
0.00%
0/3
|
|
Nervous system disorders
Migraine
|
20.0%
1/5 • Number of events 1
|
0.00%
0/3
|
|
Psychiatric disorders
Mood swings
|
60.0%
3/5 • Number of events 5
|
66.7%
2/3 • Number of events 2
|
|
Gastrointestinal disorders
Mouth haemorrhage
|
40.0%
2/5 • Number of events 3
|
0.00%
0/3
|
|
Gastrointestinal disorders
Mouth ulceration
|
40.0%
2/5 • Number of events 2
|
0.00%
0/3
|
|
General disorders
Mucosal haemorrhage
|
20.0%
1/5 • Number of events 2
|
0.00%
0/3
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
40.0%
2/5 • Number of events 2
|
66.7%
2/3 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Nail discomfort
|
0.00%
0/5
|
33.3%
1/3 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
20.0%
1/5 • Number of events 1
|
0.00%
0/3
|
|
Gastrointestinal disorders
Nausea
|
40.0%
2/5 • Number of events 3
|
66.7%
2/3 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/5
|
33.3%
1/3 • Number of events 3
|
|
Psychiatric disorders
Nightmare
|
40.0%
2/5 • Number of events 2
|
66.7%
2/3 • Number of events 2
|
|
General disorders
Non-cardiac chest pain
|
20.0%
1/5 • Number of events 1
|
0.00%
0/3
|
|
Investigations
Occult blood
|
20.0%
1/5 • Number of events 1
|
0.00%
0/3
|
|
General disorders
Oedema
|
20.0%
1/5 • Number of events 1
|
0.00%
0/3
|
|
Skin and subcutaneous tissue disorders
Oil acne
|
20.0%
1/5 • Number of events 1
|
0.00%
0/3
|
|
Skin and subcutaneous tissue disorders
Onycholysis
|
20.0%
1/5 • Number of events 1
|
0.00%
0/3
|
|
Gastrointestinal disorders
Oral disorder
|
0.00%
0/5
|
33.3%
1/3 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
20.0%
1/5 • Number of events 1
|
0.00%
0/3
|
|
Cardiac disorders
Palpitations
|
60.0%
3/5 • Number of events 5
|
0.00%
0/3
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
60.0%
3/5 • Number of events 4
|
66.7%
2/3 • Number of events 2
|
|
Infections and infestations
Pharyngitis
|
20.0%
1/5 • Number of events 1
|
0.00%
0/3
|
|
Nervous system disorders
Poor quality sleep
|
40.0%
2/5 • Number of events 3
|
33.3%
1/3 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary congestion
|
20.0%
1/5 • Number of events 1
|
0.00%
0/3
|
|
General disorders
Pyrexia
|
20.0%
1/5 • Number of events 1
|
0.00%
0/3
|
|
Skin and subcutaneous tissue disorders
Rash
|
20.0%
1/5 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
|
Psychiatric disorders
Restlessness
|
80.0%
4/5 • Number of events 4
|
66.7%
2/3 • Number of events 3
|
|
Eye disorders
Scleral haemorrhage
|
0.00%
0/5
|
33.3%
1/3 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Seborrhoea
|
20.0%
1/5 • Number of events 1
|
0.00%
0/3
|
|
Skin and subcutaneous tissue disorders
Skin discolouration
|
0.00%
0/5
|
33.3%
1/3 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
0.00%
0/5
|
33.3%
1/3 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Skin reaction
|
0.00%
0/5
|
33.3%
1/3 • Number of events 1
|
|
General disorders
Swelling
|
20.0%
1/5 • Number of events 1
|
0.00%
0/3
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
0.00%
0/5
|
33.3%
1/3 • Number of events 2
|
|
Nervous system disorders
Syncope
|
0.00%
0/5
|
33.3%
1/3 • Number of events 1
|
|
General disorders
Thirst
|
80.0%
4/5 • Number of events 5
|
66.7%
2/3 • Number of events 3
|
|
Nervous system disorders
Tremor
|
20.0%
1/5 • Number of events 1
|
66.7%
2/3 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/5
|
33.3%
1/3 • Number of events 1
|
|
Infections and infestations
Viral upper respiratory tract
|
0.00%
0/5
|
33.3%
1/3 • Number of events 1
|
|
Eye disorders
Vision blurred
|
100.0%
5/5 • Number of events 6
|
0.00%
0/3
|
|
Eye disorders
Visual acuity reduced
|
20.0%
1/5 • Number of events 1
|
0.00%
0/3
|
|
Eye disorders
Visual impairment
|
0.00%
0/5
|
33.3%
1/3 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
60.0%
3/5 • Number of events 3
|
0.00%
0/3
|
|
Metabolism and nutrition disorders
Weight fluctuation
|
20.0%
1/5 • Number of events 1
|
0.00%
0/3
|
|
Injury, poisoning and procedural complications
Compensatory sweating
|
20.0%
1/5 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
|
Gastrointestinal disorders
Dyspepsia
|
20.0%
1/5 • Number of events 1
|
0.00%
0/3
|
|
Surgical and medical procedures
Menstrual cycle management
|
20.0%
1/5 • Number of events 1
|
0.00%
0/3
|
|
Skin and subcutaneous tissue disorders
Skin discomfort
|
0.00%
0/5
|
33.3%
1/3 • Number of events 1
|
|
Infections and infestations
Paronychia
|
20.0%
1/5 • Number of events 1
|
0.00%
0/3
|
Additional Information
Susan F. Assmann, PhD
New England Research Institutes, Inc.
Phone: 617-923-7747
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place