Trial Outcomes & Findings for A Study Evaluating the Addition of MabThera (Rituximab) to Standard Treatment in Patients With Idiopathic Thrombocytopenic Purpura (ITP) (NCT NCT00770562)
NCT ID: NCT00770562
Last Updated: 2014-10-22
Results Overview
Sustained response defined as a platelet count of greater than or equal to (≥) 50x10\^9/L at 6 months (Week 24) after the initial treatment. Participants failing therapy before Month 6 (Week 24) and treated in other ways were considered failures.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
103 participants
Primary outcome timeframe
Week 24
Results posted on
2014-10-22
Participant Flow
Participant milestones
| Measure |
Arm A: Dexamethasone
Participants received 40 milligrams (mg) dexamethasone, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4). Participants in this treatment arm who failed to achieve a sustained response and had a platelet count of less than or equal to (≤)20 x 10\^9 platelets per liter (L; from Day 30 up to end of 6 months) were treated with salvage treatment of dexamethasone 40 mg, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4) and rituximab 375 mg per square meter (mg/m\^2), intravenously (IV), with premedication of oral acetaminophen 500 mg and chlorpheniramine 10 mg IV on Days 7, 14, 21, and 28.
|
Arm B: Dexamethasone + Rituximab
Participants received dexamethasone 40 mg, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4) and rituximab 375 mg/m\^2, IV, with premedication of oral acetaminophen 500 mg and chlorpheniramine 10 mg IV on Days 7, 14, 21, and 28. Nonresponsive participants with platelets less than (\<) 20 x10\^9/L or with active bleeding could have also received an additional treatment course of dexamethasone 40 mg, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4) and rituximab 375 mg/m\^2, IV on Days 7, 14, 21, and 28 administered with immunoglobulin (IgG) IV (at investigator discretion) and/or low/medium dose steroids (at investigator discretion) on Days 7, 14, 21, and 28.
|
|---|---|---|
|
Overall Study
STARTED
|
53
|
50
|
|
Overall Study
COMPLETED
|
52
|
49
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Arm A: Dexamethasone
Participants received 40 milligrams (mg) dexamethasone, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4). Participants in this treatment arm who failed to achieve a sustained response and had a platelet count of less than or equal to (≤)20 x 10\^9 platelets per liter (L; from Day 30 up to end of 6 months) were treated with salvage treatment of dexamethasone 40 mg, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4) and rituximab 375 mg per square meter (mg/m\^2), intravenously (IV), with premedication of oral acetaminophen 500 mg and chlorpheniramine 10 mg IV on Days 7, 14, 21, and 28.
|
Arm B: Dexamethasone + Rituximab
Participants received dexamethasone 40 mg, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4) and rituximab 375 mg/m\^2, IV, with premedication of oral acetaminophen 500 mg and chlorpheniramine 10 mg IV on Days 7, 14, 21, and 28. Nonresponsive participants with platelets less than (\<) 20 x10\^9/L or with active bleeding could have also received an additional treatment course of dexamethasone 40 mg, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4) and rituximab 375 mg/m\^2, IV on Days 7, 14, 21, and 28 administered with immunoglobulin (IgG) IV (at investigator discretion) and/or low/medium dose steroids (at investigator discretion) on Days 7, 14, 21, and 28.
|
|---|---|---|
|
Overall Study
Did not take treatment
|
1
|
1
|
Baseline Characteristics
A Study Evaluating the Addition of MabThera (Rituximab) to Standard Treatment in Patients With Idiopathic Thrombocytopenic Purpura (ITP)
Baseline characteristics by cohort
| Measure |
Arm A: Dexamethasone
n=52 Participants
Participants received 40 mg dexamethasone, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4). Participants in this treatment arm who failed to achieve a sustained response and had a platelet count of ≤20 x 10\^9 platelets per liter (L; from Day 30 up to end of 6 months) were treated with salvage treatment of dexamethasone 40 mg, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4) and rituximab 375 mg/m\^2, IV, with premedication of oral acetaminophen 500 mg and chlorpheniramine 10 mg IV on Days 7, 14, 21, and 28.
|
Arm B: Dexamethasone + Rituximab
n=49 Participants
Participants received dexamethasone 40 mg, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4) and rituximab 375 mg per square meter (mg/m\^2), IV, with premedication of oral acetaminophen 500 mg and chlorpheniramine 10 mg IV on Days 7, 14, 21, and 28. Nonresponsive participants with platelets \<20 x10\^9/L or with active bleeding could have also received an additional treatment course of dexamethasone 40 mg, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4) and rituximab 375 mg/m\^2, IV on Days 7, 14, 21, and 28 administered with IgG IV (at investigator discretion) and/or low/medium dose steroids (at investigator discretion) on Days 7, 14, 21, and 28.
|
Total
n=101 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
47 years
STANDARD_DEVIATION 19 • n=5 Participants
|
49 years
STANDARD_DEVIATION 16 • n=7 Participants
|
48.41 years
STANDARD_DEVIATION 18.03 • n=5 Participants
|
|
Sex: Female, Male
Female
|
33 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 24Population: The Intent-to-Treat (ITT) population includes all participants who were randomized, who received at least (\<) 1 dose of study medication, and who had at least 1 follow-up contact.
Sustained response defined as a platelet count of greater than or equal to (≥) 50x10\^9/L at 6 months (Week 24) after the initial treatment. Participants failing therapy before Month 6 (Week 24) and treated in other ways were considered failures.
Outcome measures
| Measure |
Arm A: Dexamethasone
n=52 Participants
Participants received 40 mg dexamethasone, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4). Participants in this treatment arm who failed to achieve a sustained response and had a platelet count of ≤20 x 10\^9/L (from Day 30 up to end of 6 months) were treated with salvage treatment of dexamethasone 40 mg, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4) and rituximab 375 mg/m\^2, IV, with premedication of oral acetaminophen 500 mg and chlorpheniramine 10 mg IV on Days 7, 14, 21, and 28.
|
Arm B: Dexamethasone + Rituximab
n=49 Participants
Participants received dexamethasone 40 mg, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4) and rituximab 375 mg/m\^2, IV, with premedication of oral acetaminophen 500 mg and chlorpheniramine 10 mg IV on Days 7, 14, 21, and 28. Nonresponsive participants with platelets \<20 x10\^9/L or with active bleeding could have also received an additional treatment course of dexamethasone 40 mg, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4) and rituximab 375 mg/m\^2, IV on Days 7, 14, 21, and 28 administered with IgG IV (at investigator discretion) and/or low/medium dose steroids (at investigator discretion) on Days 7, 14, 21, and 28.
|
|---|---|---|
|
Percentage of Participants With a Sustained Response
|
36 percentage of participants
|
63 percentage of participants
|
SECONDARY outcome
Timeframe: Week 4Population: ITT population; excluding participants who received additional steroid therapy or IV Ig course during the first month of therapy.
Initial response was defined as an increase in platelet count of ≥50x10\^9/L by Day 30 (Week 4) after the start of treatment in either treatment arm.
Outcome measures
| Measure |
Arm A: Dexamethasone
n=44 Participants
Participants received 40 mg dexamethasone, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4). Participants in this treatment arm who failed to achieve a sustained response and had a platelet count of ≤20 x 10\^9/L (from Day 30 up to end of 6 months) were treated with salvage treatment of dexamethasone 40 mg, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4) and rituximab 375 mg/m\^2, IV, with premedication of oral acetaminophen 500 mg and chlorpheniramine 10 mg IV on Days 7, 14, 21, and 28.
|
Arm B: Dexamethasone + Rituximab
n=25 Participants
Participants received dexamethasone 40 mg, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4) and rituximab 375 mg/m\^2, IV, with premedication of oral acetaminophen 500 mg and chlorpheniramine 10 mg IV on Days 7, 14, 21, and 28. Nonresponsive participants with platelets \<20 x10\^9/L or with active bleeding could have also received an additional treatment course of dexamethasone 40 mg, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4) and rituximab 375 mg/m\^2, IV on Days 7, 14, 21, and 28 administered with IgG IV (at investigator discretion) and/or low/medium dose steroids (at investigator discretion) on Days 7, 14, 21, and 28.
|
|---|---|---|
|
Percentage of Participants With an Initial Response
|
27 percentage of participants
|
68 percentage of participants
|
SECONDARY outcome
Timeframe: Week 4Population: ITT population; excluding participants who received additional steroid therapy or IV Ig course during the first month of therapy.
Initial complete response was defined as an increase in platelet count of ≥100x10\^9/L by Day 30 (Week 4) after the initiation of treatment in either treatment arm.
Outcome measures
| Measure |
Arm A: Dexamethasone
n=44 Participants
Participants received 40 mg dexamethasone, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4). Participants in this treatment arm who failed to achieve a sustained response and had a platelet count of ≤20 x 10\^9/L (from Day 30 up to end of 6 months) were treated with salvage treatment of dexamethasone 40 mg, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4) and rituximab 375 mg/m\^2, IV, with premedication of oral acetaminophen 500 mg and chlorpheniramine 10 mg IV on Days 7, 14, 21, and 28.
|
Arm B: Dexamethasone + Rituximab
n=25 Participants
Participants received dexamethasone 40 mg, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4) and rituximab 375 mg/m\^2, IV, with premedication of oral acetaminophen 500 mg and chlorpheniramine 10 mg IV on Days 7, 14, 21, and 28. Nonresponsive participants with platelets \<20 x10\^9/L or with active bleeding could have also received an additional treatment course of dexamethasone 40 mg, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4) and rituximab 375 mg/m\^2, IV on Days 7, 14, 21, and 28 administered with IgG IV (at investigator discretion) and/or low/medium dose steroids (at investigator discretion) on Days 7, 14, 21, and 28.
|
|---|---|---|
|
Percentage of Participants With an Initial Complete Response
|
23 percentage of participants
|
48 percentage of participants
|
Adverse Events
Arm A: Dexamethasone
Serious events: 1 serious events
Other events: 25 other events
Deaths: 0 deaths
Arm B: Dexamethasone + Rituximab
Serious events: 3 serious events
Other events: 37 other events
Deaths: 0 deaths
Salvage Therapy
Serious events: 3 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm A: Dexamethasone
n=52 participants at risk
Participants received 40 mg dexamethasone, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4).
|
Arm B: Dexamethasone + Rituximab
n=49 participants at risk
Participants received dexamethasone 40 mg, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4) and rituximab 375 mg/m\^2, IV, with premedication of oral acetaminophen 500 mg and chlorpheniramine 10 mg IV on Days 7, 14, 21, and 28.
|
Salvage Therapy
n=27 participants at risk
Nonresponsive (failed to achieve a sustained response) participants from Arm A (dexamethasone monotherapy) who had a platelet count of ≤20 x 10\^9/L (from Day 30 up to end of 6 months) were treated with salvage treatment of dexamethasone 40 mg, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4) and rituximab 375 mg/m\^2, IV, with premedication of oral acetaminophen 500 mg and chlorpheniramine 10 mg IV on Days 7, 14, 21, and 28. Nonresponsive participants from Arm B (dexamethasone + rituximab) with platelets \<20 x10\^9/L or with active bleeding were treated with salvage therapy of dexamethasone 40 mg, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4) and rituximab 375 mg/m\^2, IV on Days 7, 14, 21, and 28 administered with IgG IV (at investigator discretion) and/or low/medium dose steroids (at investigator discretion) on Days 7, 14, 21, and 28.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Hemorrhagic syndrome and low platelet
|
0.00%
0/52 • 6 months
|
0.00%
0/49 • 6 months
|
3.7%
1/27 • 6 months
|
|
Blood and lymphatic system disorders
Hemorrhage syndrome
|
0.00%
0/52 • 6 months
|
2.0%
1/49 • 6 months
|
0.00%
0/27 • 6 months
|
|
Blood and lymphatic system disorders
Platelet count decreased
|
0.00%
0/52 • 6 months
|
0.00%
0/49 • 6 months
|
3.7%
1/27 • 6 months
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/52 • 6 months
|
2.0%
1/49 • 6 months
|
0.00%
0/27 • 6 months
|
|
Infections and infestations
Interstitial pneumonia
|
0.00%
0/52 • 6 months
|
2.0%
1/49 • 6 months
|
0.00%
0/27 • 6 months
|
|
Injury, poisoning and procedural complications
Rib fracture
|
1.9%
1/52 • 6 months
|
0.00%
0/49 • 6 months
|
0.00%
0/27 • 6 months
|
|
Nervous system disorders
Convulsion
|
0.00%
0/52 • 6 months
|
0.00%
0/49 • 6 months
|
3.7%
1/27 • 6 months
|
|
Nervous system disorders
Seizure
|
0.00%
0/52 • 6 months
|
0.00%
0/49 • 6 months
|
3.7%
1/27 • 6 months
|
|
Nervous system disorders
TIA
|
0.00%
0/52 • 6 months
|
0.00%
0/49 • 6 months
|
3.7%
1/27 • 6 months
|
Other adverse events
| Measure |
Arm A: Dexamethasone
n=52 participants at risk
Participants received 40 mg dexamethasone, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4).
|
Arm B: Dexamethasone + Rituximab
n=49 participants at risk
Participants received dexamethasone 40 mg, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4) and rituximab 375 mg/m\^2, IV, with premedication of oral acetaminophen 500 mg and chlorpheniramine 10 mg IV on Days 7, 14, 21, and 28.
|
Salvage Therapy
n=27 participants at risk
Nonresponsive (failed to achieve a sustained response) participants from Arm A (dexamethasone monotherapy) who had a platelet count of ≤20 x 10\^9/L (from Day 30 up to end of 6 months) were treated with salvage treatment of dexamethasone 40 mg, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4) and rituximab 375 mg/m\^2, IV, with premedication of oral acetaminophen 500 mg and chlorpheniramine 10 mg IV on Days 7, 14, 21, and 28. Nonresponsive participants from Arm B (dexamethasone + rituximab) with platelets \<20 x10\^9/L or with active bleeding were treated with salvage therapy of dexamethasone 40 mg, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4) and rituximab 375 mg/m\^2, IV on Days 7, 14, 21, and 28 administered with IgG IV (at investigator discretion) and/or low/medium dose steroids (at investigator discretion) on Days 7, 14, 21, and 28.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/52 • 6 months
|
2.0%
1/49 • 6 months
|
0.00%
0/27 • 6 months
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/52 • 6 months
|
0.00%
0/49 • 6 months
|
7.4%
2/27 • 6 months
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/52 • 6 months
|
0.00%
0/49 • 6 months
|
3.7%
1/27 • 6 months
|
|
Cardiac disorders
Bradycardia
|
1.9%
1/52 • 6 months
|
0.00%
0/49 • 6 months
|
0.00%
0/27 • 6 months
|
|
Eye disorders
Conjunctival haemorrhage
|
1.9%
1/52 • 6 months
|
0.00%
0/49 • 6 months
|
0.00%
0/27 • 6 months
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/52 • 6 months
|
0.00%
0/49 • 6 months
|
3.7%
1/27 • 6 months
|
|
Gastrointestinal disorders
Abdominal pain
|
1.9%
1/52 • 6 months
|
2.0%
1/49 • 6 months
|
0.00%
0/27 • 6 months
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.9%
1/52 • 6 months
|
14.3%
7/49 • 6 months
|
7.4%
2/27 • 6 months
|
|
Gastrointestinal disorders
Constipation
|
1.9%
1/52 • 6 months
|
2.0%
1/49 • 6 months
|
7.4%
2/27 • 6 months
|
|
Blood and lymphatic system disorders
Anaemia
|
3.8%
2/52 • 6 months
|
4.1%
2/49 • 6 months
|
3.7%
1/27 • 6 months
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/52 • 6 months
|
10.2%
5/49 • 6 months
|
0.00%
0/27 • 6 months
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/52 • 6 months
|
2.0%
1/49 • 6 months
|
0.00%
0/27 • 6 months
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/52 • 6 months
|
0.00%
0/49 • 6 months
|
3.7%
1/27 • 6 months
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/52 • 6 months
|
2.0%
1/49 • 6 months
|
0.00%
0/27 • 6 months
|
|
Gastrointestinal disorders
Gingival bleeding
|
1.9%
1/52 • 6 months
|
6.1%
3/49 • 6 months
|
3.7%
1/27 • 6 months
|
|
Gastrointestinal disorders
Haemorrhoids
|
1.9%
1/52 • 6 months
|
0.00%
0/49 • 6 months
|
3.7%
1/27 • 6 months
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/52 • 6 months
|
2.0%
1/49 • 6 months
|
0.00%
0/27 • 6 months
|
|
General disorders
Adverse drug reaction
|
0.00%
0/52 • 6 months
|
0.00%
0/49 • 6 months
|
3.7%
1/27 • 6 months
|
|
General disorders
Asthenia
|
3.8%
2/52 • 6 months
|
10.2%
5/49 • 6 months
|
0.00%
0/27 • 6 months
|
|
General disorders
Chest pain
|
0.00%
0/52 • 6 months
|
2.0%
1/49 • 6 months
|
0.00%
0/27 • 6 months
|
|
General disorders
Chills
|
0.00%
0/52 • 6 months
|
4.1%
2/49 • 6 months
|
0.00%
0/27 • 6 months
|
|
General disorders
Fatigue
|
0.00%
0/52 • 6 months
|
2.0%
1/49 • 6 months
|
0.00%
0/27 • 6 months
|
|
General disorders
Gravitational oedema
|
0.00%
0/52 • 6 months
|
2.0%
1/49 • 6 months
|
0.00%
0/27 • 6 months
|
|
General disorders
Hyperpyrexia
|
0.00%
0/52 • 6 months
|
0.00%
0/49 • 6 months
|
3.7%
1/27 • 6 months
|
|
General disorders
Malaise
|
0.00%
0/52 • 6 months
|
0.00%
0/49 • 6 months
|
3.7%
1/27 • 6 months
|
|
General disorders
Mucosal hyperaemia
|
0.00%
0/52 • 6 months
|
2.0%
1/49 • 6 months
|
0.00%
0/27 • 6 months
|
|
General disorders
Mucosal inflammation
|
1.9%
1/52 • 6 months
|
0.00%
0/49 • 6 months
|
0.00%
0/27 • 6 months
|
|
General disorders
Oedema peripheral
|
3.8%
2/52 • 6 months
|
0.00%
0/49 • 6 months
|
0.00%
0/27 • 6 months
|
|
General disorders
Pyrexia
|
1.9%
1/52 • 6 months
|
20.4%
10/49 • 6 months
|
18.5%
5/27 • 6 months
|
|
Hepatobiliary disorders
Biliary colic
|
1.9%
1/52 • 6 months
|
0.00%
0/49 • 6 months
|
0.00%
0/27 • 6 months
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/52 • 6 months
|
4.1%
2/49 • 6 months
|
0.00%
0/27 • 6 months
|
|
Infections and infestations
Acute sinusitis
|
0.00%
0/52 • 6 months
|
2.0%
1/49 • 6 months
|
0.00%
0/27 • 6 months
|
|
Infections and infestations
Bronchitis acute
|
0.00%
0/52 • 6 months
|
0.00%
0/49 • 6 months
|
3.7%
1/27 • 6 months
|
|
Infections and infestations
Cystitis
|
0.00%
0/52 • 6 months
|
2.0%
1/49 • 6 months
|
0.00%
0/27 • 6 months
|
|
Infections and infestations
Folliculitis
|
1.9%
1/52 • 6 months
|
0.00%
0/49 • 6 months
|
0.00%
0/27 • 6 months
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/52 • 6 months
|
4.1%
2/49 • 6 months
|
0.00%
0/27 • 6 months
|
|
Infections and infestations
Helicobacter infection
|
1.9%
1/52 • 6 months
|
4.1%
2/49 • 6 months
|
0.00%
0/27 • 6 months
|
|
Infections and infestations
Herpes simplex
|
0.00%
0/52 • 6 months
|
2.0%
1/49 • 6 months
|
0.00%
0/27 • 6 months
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/52 • 6 months
|
0.00%
0/49 • 6 months
|
3.7%
1/27 • 6 months
|
|
Infections and infestations
Influenza
|
0.00%
0/52 • 6 months
|
4.1%
2/49 • 6 months
|
0.00%
0/27 • 6 months
|
|
Infections and infestations
Lung infection
|
1.9%
1/52 • 6 months
|
0.00%
0/49 • 6 months
|
0.00%
0/27 • 6 months
|
|
Infections and infestations
Nasopharyngitis
|
3.8%
2/52 • 6 months
|
8.2%
4/49 • 6 months
|
0.00%
0/27 • 6 months
|
|
Infections and infestations
Pharyngitis
|
1.9%
1/52 • 6 months
|
4.1%
2/49 • 6 months
|
0.00%
0/27 • 6 months
|
|
Infections and infestations
Tinea versicolour
|
0.00%
0/52 • 6 months
|
2.0%
1/49 • 6 months
|
0.00%
0/27 • 6 months
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/52 • 6 months
|
4.1%
2/49 • 6 months
|
7.4%
2/27 • 6 months
|
|
Infections and infestations
Tracheitis
|
0.00%
0/52 • 6 months
|
2.0%
1/49 • 6 months
|
0.00%
0/27 • 6 months
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/52 • 6 months
|
2.0%
1/49 • 6 months
|
0.00%
0/27 • 6 months
|
|
Infections and infestations
Urinary tract infection
|
1.9%
1/52 • 6 months
|
0.00%
0/49 • 6 months
|
0.00%
0/27 • 6 months
|
|
Injury, poisoning and procedural complications
Injury
|
1.9%
1/52 • 6 months
|
0.00%
0/49 • 6 months
|
0.00%
0/27 • 6 months
|
|
Injury, poisoning and procedural complications
Traumatic haematoma
|
1.9%
1/52 • 6 months
|
2.0%
1/49 • 6 months
|
0.00%
0/27 • 6 months
|
|
Injury, poisoning and procedural complications
Traumatic haemorrhage
|
1.9%
1/52 • 6 months
|
2.0%
1/49 • 6 months
|
0.00%
0/27 • 6 months
|
|
Investigations
Aspartate aminotransferase increased
|
1.9%
1/52 • 6 months
|
0.00%
0/49 • 6 months
|
0.00%
0/27 • 6 months
|
|
Investigations
Blood amylase increased
|
0.00%
0/52 • 6 months
|
2.0%
1/49 • 6 months
|
0.00%
0/27 • 6 months
|
|
Investigations
Blood pressure abnormal
|
0.00%
0/52 • 6 months
|
2.0%
1/49 • 6 months
|
0.00%
0/27 • 6 months
|
|
Investigations
Blood pressure increased
|
0.00%
0/52 • 6 months
|
0.00%
0/49 • 6 months
|
3.7%
1/27 • 6 months
|
|
Investigations
Gamma-glutamyltransferase increased
|
1.9%
1/52 • 6 months
|
0.00%
0/49 • 6 months
|
0.00%
0/27 • 6 months
|
|
Investigations
Lipase increased
|
0.00%
0/52 • 6 months
|
2.0%
1/49 • 6 months
|
0.00%
0/27 • 6 months
|
|
Investigations
Oxygen saturation decreased
|
0.00%
0/52 • 6 months
|
2.0%
1/49 • 6 months
|
0.00%
0/27 • 6 months
|
|
Investigations
Platelet count decreased
|
3.8%
2/52 • 6 months
|
0.00%
0/49 • 6 months
|
7.4%
2/27 • 6 months
|
|
Investigations
Transaminases increased
|
5.8%
3/52 • 6 months
|
4.1%
2/49 • 6 months
|
0.00%
0/27 • 6 months
|
|
Metabolism and nutrition disorders
Fluid retention
|
0.00%
0/52 • 6 months
|
2.0%
1/49 • 6 months
|
0.00%
0/27 • 6 months
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/52 • 6 months
|
0.00%
0/49 • 6 months
|
3.7%
1/27 • 6 months
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
1.9%
1/52 • 6 months
|
0.00%
0/49 • 6 months
|
0.00%
0/27 • 6 months
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
1.9%
1/52 • 6 months
|
2.0%
1/49 • 6 months
|
0.00%
0/27 • 6 months
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/52 • 6 months
|
4.1%
2/49 • 6 months
|
0.00%
0/27 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/52 • 6 months
|
2.0%
1/49 • 6 months
|
3.7%
1/27 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/52 • 6 months
|
2.0%
1/49 • 6 months
|
0.00%
0/27 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.9%
1/52 • 6 months
|
2.0%
1/49 • 6 months
|
7.4%
2/27 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/52 • 6 months
|
2.0%
1/49 • 6 months
|
0.00%
0/27 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/52 • 6 months
|
2.0%
1/49 • 6 months
|
0.00%
0/27 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
1.9%
1/52 • 6 months
|
0.00%
0/49 • 6 months
|
0.00%
0/27 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/52 • 6 months
|
0.00%
0/49 • 6 months
|
3.7%
1/27 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
1.9%
1/52 • 6 months
|
0.00%
0/49 • 6 months
|
0.00%
0/27 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/52 • 6 months
|
2.0%
1/49 • 6 months
|
0.00%
0/27 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/52 • 6 months
|
4.1%
2/49 • 6 months
|
0.00%
0/27 • 6 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.00%
0/52 • 6 months
|
2.0%
1/49 • 6 months
|
0.00%
0/27 • 6 months
|
|
Nervous system disorders
Cognitive disorder
|
0.00%
0/52 • 6 months
|
2.0%
1/49 • 6 months
|
0.00%
0/27 • 6 months
|
|
Nervous system disorders
Dizziness
|
1.9%
1/52 • 6 months
|
2.0%
1/49 • 6 months
|
3.7%
1/27 • 6 months
|
|
Nervous system disorders
Headache
|
5.8%
3/52 • 6 months
|
12.2%
6/49 • 6 months
|
7.4%
2/27 • 6 months
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/52 • 6 months
|
0.00%
0/49 • 6 months
|
3.7%
1/27 • 6 months
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/52 • 6 months
|
0.00%
0/49 • 6 months
|
3.7%
1/27 • 6 months
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/52 • 6 months
|
2.0%
1/49 • 6 months
|
0.00%
0/27 • 6 months
|
|
Psychiatric disorders
Depression
|
0.00%
0/52 • 6 months
|
4.1%
2/49 • 6 months
|
0.00%
0/27 • 6 months
|
|
Psychiatric disorders
Insomnia
|
3.8%
2/52 • 6 months
|
2.0%
1/49 • 6 months
|
0.00%
0/27 • 6 months
|
|
Renal and urinary disorders
Dysuria
|
1.9%
1/52 • 6 months
|
0.00%
0/49 • 6 months
|
0.00%
0/27 • 6 months
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/52 • 6 months
|
0.00%
0/49 • 6 months
|
3.7%
1/27 • 6 months
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/52 • 6 months
|
0.00%
0/49 • 6 months
|
3.7%
1/27 • 6 months
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/52 • 6 months
|
0.00%
0/49 • 6 months
|
3.7%
1/27 • 6 months
|
|
Renal and urinary disorders
Strangury
|
0.00%
0/52 • 6 months
|
2.0%
1/49 • 6 months
|
0.00%
0/27 • 6 months
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.00%
0/52 • 6 months
|
0.00%
0/49 • 6 months
|
3.7%
1/27 • 6 months
|
|
Reproductive system and breast disorders
Metrorrhagia
|
1.9%
1/52 • 6 months
|
4.1%
2/49 • 6 months
|
0.00%
0/27 • 6 months
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.00%
0/52 • 6 months
|
2.0%
1/49 • 6 months
|
0.00%
0/27 • 6 months
|
|
Reproductive system and breast disorders
Prostatitis
|
1.9%
1/52 • 6 months
|
0.00%
0/49 • 6 months
|
0.00%
0/27 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/52 • 6 months
|
0.00%
0/49 • 6 months
|
3.7%
1/27 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.6%
5/52 • 6 months
|
12.2%
6/49 • 6 months
|
0.00%
0/27 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/52 • 6 months
|
6.1%
3/49 • 6 months
|
0.00%
0/27 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
1.9%
1/52 • 6 months
|
0.00%
0/49 • 6 months
|
0.00%
0/27 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
1.9%
1/52 • 6 months
|
0.00%
0/49 • 6 months
|
0.00%
0/27 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
1.9%
1/52 • 6 months
|
0.00%
0/49 • 6 months
|
0.00%
0/27 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
1.9%
1/52 • 6 months
|
2.0%
1/49 • 6 months
|
0.00%
0/27 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/52 • 6 months
|
2.0%
1/49 • 6 months
|
0.00%
0/27 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Tonsillar disorder
|
0.00%
0/52 • 6 months
|
2.0%
1/49 • 6 months
|
0.00%
0/27 • 6 months
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
1.9%
1/52 • 6 months
|
0.00%
0/49 • 6 months
|
0.00%
0/27 • 6 months
|
|
Skin and subcutaneous tissue disorders
Erythema
|
1.9%
1/52 • 6 months
|
4.1%
2/49 • 6 months
|
3.7%
1/27 • 6 months
|
|
Skin and subcutaneous tissue disorders
Periorbital oedema
|
1.9%
1/52 • 6 months
|
0.00%
0/49 • 6 months
|
0.00%
0/27 • 6 months
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
7.7%
4/52 • 6 months
|
0.00%
0/49 • 6 months
|
3.7%
1/27 • 6 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
1.9%
1/52 • 6 months
|
0.00%
0/49 • 6 months
|
0.00%
0/27 • 6 months
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
1.9%
1/52 • 6 months
|
0.00%
0/49 • 6 months
|
0.00%
0/27 • 6 months
|
|
Skin and subcutaneous tissue disorders
Purpura
|
3.8%
2/52 • 6 months
|
0.00%
0/49 • 6 months
|
0.00%
0/27 • 6 months
|
|
Skin and subcutaneous tissue disorders
Skin discolouration
|
0.00%
0/52 • 6 months
|
2.0%
1/49 • 6 months
|
0.00%
0/27 • 6 months
|
|
Vascular disorders
Arteriosclerosis
|
0.00%
0/52 • 6 months
|
0.00%
0/49 • 6 months
|
3.7%
1/27 • 6 months
|
|
Vascular disorders
Hypertension
|
1.9%
1/52 • 6 months
|
2.0%
1/49 • 6 months
|
0.00%
0/27 • 6 months
|
|
Vascular disorders
Hypotension
|
1.9%
1/52 • 6 months
|
2.0%
1/49 • 6 months
|
3.7%
1/27 • 6 months
|
|
Vascular disorders
Phlebitis superficial
|
0.00%
0/52 • 6 months
|
2.0%
1/49 • 6 months
|
0.00%
0/27 • 6 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights
- Publication restrictions are in place
Restriction type: OTHER